Clinical Trial: Assessing Cognitive Behavioral Therapy in Irritable Bowel Syndrome University of Southampton, UK, 2015

March 15, 2015

The University of Southampton, in collaboration with Kings College, London, has an ongoing multi-center clinical trial begun in 2013 and expected to be published in 2018 comparing the clinical and cost effectiveness of therapist cognitive behavioral therapy and lower intensity web-based cognitive behavioral therapy for people with refractory irritable bowel syndrome (IBS).

A total of 495 volunteers with IBS have been or will be recruited from primary and secondary care in Southampton and London and randomized into one of the two groups. The therapist CBT group receives 6 one-hour telephone sessions with a therapist over a period of 9 weeks, plus two one-hour followup calls at 4 months and 8 months following treatment for a total of 8 hours contact time with the therapist.  The lower intensity web-based CBT group receives a web-based self-management program plus 3 half-hour telephone sessions with a therapist over 9 weeks, plus two half-hour followup up calls at 4 months and 8 months following treatment for a total of 2 1/2 hours contact time with a therapist. The original listing can be found here on the University of Southampton website.  ACTIB Cognitive Behavioral Therapy Study, Southampton For further details or to volunteer, please contact Gilly O’Reilly, Trial Manager, at gor@soton.ac.uk

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While IBS Impact attempts to highlight a diversity of available opportunities, this is not intended as an exhaustive resource. Previous posts on open clinical trials for IBS can be found by clicking the clinical trials category in the blog archives on the upper right sidebar of this blog. We also have a page for IBS studies on the main IBS Impact site. Because studies stop accepting new volunteers or are completed over time, please check the post date on this blog, or the last update date on studies page, to verify that the study you are interested in is relatively recent rather than from a few years ago. Depending on how you accessed this blog, the post date will appear either at the top or at the bottom of the post, and is occasionally included in the post title. On the studies page on the main site, the date of the last update is at both the top and the bottom of the page. The research and links pages and the July 26, 2011 post provide additional general resources.

We welcome researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies they wish to be considered for posting or if an existing listing needs to be updated. Contact links for the founder/listowner and the webmaster can be found on the home page of the main IBS Impact website.

IBS Impact makes these study announcements available for general information, and encourages its members and site visitors to make their own individual, informed choices about their potential participation in any study. IBS Impact, as an entity, is not directly affiliated with any research sponsor and receives no funding from any source for studies or links we feature on this blog, the main site or social media.


NICE Guidelines in the United Kingdom for Adult Irritable Bowel Syndrome (IBS) Updated for 2015

March 6, 2015

Last month, February 2015, the National Institute for Health and Care Excellence, formerly the National Institute for Clinical Excellence and still widely known by its original acronym NICE, released revised guidelines for the diagnosis and treatment of adults with irritable bowel syndrome (IBS) in the United Kingdom. NICE’s stated goal is to provide evidence-based information to improve the overall quality of care and reduce variation in care through the National Health Service. The committees responsible for the IBS guidelines included many professionals from a variety of academic research centers and hospitals throughout the U.K.

The last update to the NICE guidelines for IBS was in 2008. In a portion of the guidelines on its website directed to the general public,  NICE cautions that these guidelines are not intended for those with IBS who are under the age of 18 or those who have other gastrointestinal disorders such as non-ulcer dyspepsia or coeliac (celiac) disease. The guidelines are primarily for use by general practitioners/primary care physicians who are the first health professionals to assess people with possible symptoms of IBS. The relevant section of the NICE website includes several additional tools, including cost information.

With a few specific country variations, the NICE guidelines are consistent with the international Rome criteria developed by leading functional gastrointestinal disorder clinicians and researchers from several countries (currently Rome III. See page 889. Rome IV was completed in December 2014 and is expected to be published in 2016.) and best practices advocated by those same IBS experts, such as patient-centered care. For example, the NICE guidelines advise primary care providers to ask open-ended questions, to be aware that many patients will not disclose incontinence without being specifically asked, and to be sensitive to individuals for whom English is not the first language or who have disabilities that may hinder effective communication.

In general, NICE advises that IBS should be considered a possible diagnosis for people who have chronic symptoms of abdominal pain and change in bowel habits  (altered frequency or stool form) and at least two of the following additional symptoms: changes in stool passage (such as straining, urgency, incomplete evacuation), bloating, symptoms worsened by eating, or passage of mucus. Additionally, NICE states that the following common non-GI or extraintestinal symptoms can further support diagnosis of IBS: lethargy, nausea, backache and bladder symptoms.

Symptoms or circumstances that are not present in irritable bowel syndrome or otherwise warrant further investigation and referral to a specialist in gastroenterology include: unintentional and unexplained weight loss (not from changes in eating habits or physical activity), rectal bleeding, family history of bowel cancer or, for women, of ovarian cancer,  chronic frequent and/or looser stools in individuals over age 60,  anaemia (anemia), rectal or abdominal masses, and or inflammatory markers for inflammatory bowel disease (IBD).

The Rome III criteria discourage extensive testing of all people with symptoms of possible IBS. As reported on this blog on October 9, 2011, IBS experts have not considered it a diagnosis of exclusion for over two decades, and state that a properly done Rome III diagnosis is 98% accurate. As there is no clinically available test specifically for IBS at this time, many IBS experts feel that absent symptoms or risk factors for disorders other than IBS, as discussed above, routine, extensive testing is time-consuming for patients and physicians, expensive and not cost-effective, stress-producing for patients and their families, and may delay appropriate IBS education and treatment for many people with IBS, who frequently spend months or years continuing to look for other statistically unlikely causes of their symptoms. In contrast, NICE guidelines do recommend certain simple blood tests to exclude other possible diagnoses: full blood count, erythrocyte sedimentation rate (ESR) or plasma viscosity, c‑reactive protein (CRP) antibody testing for coeliac (celiac) disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG]), as well as serum CA 125 in women who meet NICE guidelines for possible ovarian cancer.  However, NICE guidelines also discourage procedures that are more invasive, involved, or generally not cost-effective. They specifically state that the following are generally not necessary to confirm a diagnosis of IBS for those who meet diagnostic criteria: ultrasound, rigid or flexible sigmoidoscopy, colonoscopy, barium enema, thyroid function test, faecal (fecal) ova or parasite tests, faecal (fecal) occult blood, and hydrogen breath tests for lactose intolerance or bacterial overgrowth. These details are mostly identical to the the 2008 version of the NICE guidelines.

The updates in the 2015 guidelines are concentrated in the treatment/management section, based on a review of research evidence and cost-effectiveness. Primary care physicians are encouraged by NICE to begin their advice to newly diagnosed people with IBS with general lifestyle and simple dietary measures. These include exercise and other relaxing leisure activities, regular meals that are not rushed, adequate fluid intake, reduction of caffeinated, carbonated, and alcoholic beverages, as well as adjustments in types or amounts of fiber, starches, fruit or sorbitol depending on specific symptoms. If these are not effective for particular individuals, NICE newly emphasizes this year that more extensive dietary exclusions, including the low-FODMAP diet, be tried only with the guidance of healthcare professionals with diet and nutrition expertise. For people with IBS who desire to try probiotics, NICE recommends that physicians advise them to continue for 4 weeks. This is a 2008 recommendation that has not changed.

If medications are needed, NICE recommends laxatives, except lactulose, for constipation-predominant IBS, and loperamide (Immodium) for diarrhea-predominant IBS. Among prescription medications, antispasmodics are considered by NICE to be the first line treatment. If those are not sufficiently effective, tricylic antidepressants are preferred by NICE over selective serotonin reuptake inhibitors (SSRIs) as the next line of treatment, with SSRIs only being used if tricyclics are ineffective. These 2008 recommendations were reviewed by the relevant NICE committee and unchanged for 2015. New for 2015,  NICE advises to physicians to be aware of potential side effects from both tricyclics and SSRIs, and to follow up regularly with their patients taking them, initially after 4 weeks, then every 6-12 months thereafter. NICE states that linaclotide (brand name Constella in Europe, Linzess in the United States) should be considered only for those with IBS with constipation (IBS-C) who have not had success with maximum doses of different classes of laxatives for at least 12 months. For 2015, NICE added a recommendation that physicians follow up after 3 months of use. The committee also considered  lubiprostone in this 2015 review, but did not find the evidence strong enough to make a specific recommendation regarding its use for IBS-C. Lubiprostone (Amitiza) is approved for IBS-C in the United States and is available in the United Kingdom for certain other types of constipation under specific strict conditions, but is not specifically approved in the U.K. for IBS-C at this time. Any prescription of lubiprostone for IBS in the U.K. would be off-label.

For those who do not respond adequately to medications within 12 months, NICE states referral to psychological interventions such as hypnotherapy or cognitive behavioral therapy can be considered. In 2015, NICE reviewed relaxation therapy, computerized cognitive behavioral therapy and mindfulness, but did not make specific recommendations about their use for IBS at this time. NICE recommends further research into computerized CBT and mindfulness, specifically their cost-effectiveness.

The 2008 guidelines include statements discouraging specific alternative medicine interventions. These were neither reviewed nor changed for 2015. Aloe vera, acupuncture and reflexology show insufficient evidence of effectiveness for IBS and are explicitly not recommended by NICE.

The full guidelines, 2015 supplement, addenda, tools and resources can be found on the NICE website at the following link:

NICE Guidelines (U.K.) for Adult Irritable Bowel Syndrome in Primary Care, February 2015

IBS Impact appreciates the work of all of the health care professionals involved in developing this revision to the NICE guidelines. Peer review is important to the scientific process and future advances. The availability of this document provides additional guidance to health care professionals and interested people with IBS in the most current standards of care for adults with IBS in the United Kingdom. When so many people with IBS, families and professionals continue to receive outdated or inaccurate information about basic aspects of IBS, an evidence-based document is an important tool in education and management of IBS.

 


“Behind the Scenes at Rome Foundation IV” Video Humanizes Functional GI Experts

February 23, 2015

In December 2014, functional gastrointestinal disorder experts from many countries, including several who are sometimes mentioned on this blog, literally met in Rome, Italy to finalize the most recent revision to the Rome criteria. The Rome criteria are the international standard used to diagnose functional gastrointestinal disorders such as irritable bowel syndrome (IBS). Some version of the Rome criteria has been in existence for over two decades. Rome III is the current version. Rome IV, which these professionals were putting the final touches on developing two months ago, will now go through the usual process for publication in a gastroenterology journal and is expected to be released for use in 2016.

It not been made public yet just what changes and improvements have been made in the details of the criteria. However, earlier this month, in his February 2, 2015  Gut Feelings  blog post, “Behind the Scenes at Rome Foundation IV: Updating FGIDs Diagnostic Criteria,” Douglas Drossman, MD, MACG, who is founder and president of the Rome Foundation, founder and president of the Drossman Center for the Education and Practice of Biopsychosocial Care, co-founder and retired co-director of the University of North Carolina Center for Functional GI Disorders, along with many other pivotal roles in the development of the field over his 40+ year career, reflects on the meeting.  He also includes a video of a bit more than 7 minutes in length showing him and his colleagues in work sessions and meetings, interacting with each other more informally in hallways and in tours of the city of Rome, and speaking to the video camera about their impressions of the meeting and their hopes for their work on the criteria and on further functional GI research and treatment. The range of countries and research institutions they currently represent is vast, and their faces and voices are reminders that there were human beings working long and diligently through this complex process.

As IBS Impact has written previously on this blog, given relatively scant, simplistic coverage of IBS in the mainstream media and some online sources, many people with IBS who have not been exposed to or taken the opportunity to access high quality, state of the science sources, tend to believe  erroneously that “nobody’s doing any research on IBS.”  (See the December 28, 2014 post). If they are aware of the Rome criteria, these tend to be an abstraction ascribed to some faceless medical “system,” not something that, if properly put into practice, IBS experts like Dr. Drossman consistently state can adequately diagnose IBS and other functional GI disorders based on symptoms with an extremely high degree of accuracy.

This lack of awareness does not only extend to people with IBS and their families though. As also reported on this blog on October 9, 2011, and still largely true today, even almost a quarter century after Rome I, functional GI experts are still battling widespread misconceptions among their own medical colleagues– primary care physicians, general gastroenterologists and nurse practitioners in local communities–  who are statistically much more likely than the experts to believe that IBS is still considered a diagnosis of exclusion, arrived at only when extensive tests have ruled out every other possibility and doctors do not know what else to call it or much about current standards of treating it. Despite the Rome Foundation members’ best efforts, as well as those of IBS organizations and advocates, these outdated notions filter down to patients and families and the public, compounding and prolonging an issue that is already entrenched but is a very basic barrier to further progress.

The best way to counter that is consistent and widespread education and awareness, which readers of this blog know IBS Impact actively encourages. The Rome Foundation is real. The Rome criteria are real, and the dedicated members of the various Rome IV working groups are real, highly experienced clinicians and researchers in the field. Take a look at Dr. Drossman’s video and see just a glimpse of behind the scenes.

IBS Impact thanks all of the experts involved in Rome IV, who are constantly working to improve diagnosis, treatment, research and functional GI education for those of us who live with these conditions and the professionals who may provide care to us. With IBS, progress is rarely quick and dramatic, and it is easy for many to lose hope that the future may bring new understanding, new options and better quality of life. But watching even a short, edited video may very possibly allow some readers that hope and insight.


Registration for Food and Drug Administration May 2015 Public Meeting for IBS, GERD, Gastroparesis, Chronic Idiopathic Constipation Patients Now Open

February 8, 2015

In April 2013, the International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, announced that the U.S. Food and Drug  Administration had chosen three functional gastrointestinal and motility disorders to be included in its  “patient focused initiative.” (See the May 1, 2013 blog post.) The FDA is responsible for the review, approval and regulation of medications in the U.S.  The entire initiative was scheduled to take place over five years and include 20 chronic medical conditions that, based on several factors  the FDA considered sufficiently serious to warrant increased attention and drug development. The three digestive disorders, irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) with regurgitation on proton pump inhibitors, and gastroparesis, were among the 16 diverse medical conditions in total that were selected during the first round. Another functional GI disorder, chronic idiopathic constipation (CIC) has since been added. The program involves public meetings and other means for the FDA to hear experiences from people affected by the selected conditions.

IFFGD/DHA has now announced that the FDA will hold one of these meetings on Monday May 11, 2015 from 1:00 pm to 5:00 pm Eastern time at the FDA campus in Silver Spring, MD. People with IBS, GERD that does not respond to standard treatments, gastroparesis and/or chronic idiopathic constipation (CIC) may now register to attend in person, attend through online webinar, or to submit comments online through the FDA comment docket. Registration will close on May 1. Further information can be found at the link below.

FDA May 11, 2015, Public Meeting on Functional GI Disorders Patient Focused Drug Development

Along with IFFGD/DHA, IBS Impact encourages people affected by the above conditions to consider participating in the public meeting or submitting comments, which is a unique opportunity to influence future FDA directions and policies regarding these disorders. It is hoped that the representation of four functional GI and motility disorders in the patient focused initiative will create other opportunities for our community and pave the way for many long-term, positive and systemic changes for us all.


January 2015 Update on American Gut, British Gut and Australian Gut Human Microbiome Projects

January 30, 2015

As many readers of this blog are probably aware, the potential roles of “good” and “bad” gut bacteria in gastrointestinal disorders like IBS is somewhat of a “hot topic” in recent years, capturing much attention in both scientific and mainstream media. This field of research appears to be promising, but despite the hype, actual scientific understanding is still at a very early stage.  On December 31, 2012, this blog reported that two separate teams of researchers, one of them known as the American Gut Project, were using the Internet and the crowdfunding sites to recruit members of the general public. For monetary donations of varying amounts, depending on the number of test kit one wished to receive, one was able to submit stool, and/or mouth or skin samples for analysis. Participants were asked to complete detailed online surveys on diet, health and daily lifestyle factors that may affect the microbiome.

The initial Indiegogo campaigns ended in February 2013. American Gut attracted about 4000 people throughout the U.S. in Phases I and II, began shipping kits in the spring of 2013 and as of this blog’s last update on October 6, 2013, had begun releasing preliminary results and individual reports to the early volunteers. Since then, in Phase III, cumulatively, over 7000 people have signed up, American Gut has revamped the participant questionnaires, and the coordinating primary investigator Rob Knight, PhD has moved recently from the University of Colorado at Boulder to a new lab at the University of California at San Diego. American Gut has forged a partnership to form the British Gut Project, headed by Tim Spector at King’s College London, MB, MSc, MD and FRCP, and Australian Gut is in the early stages of launch. See the January 18, 2015 National Public Radio interview with Dr. Knight at “One Scientist’s Race to Help Microbes Help You.” A December 20, 2014 interview with Prof. Spector can be found on the Gut Microbiota For Health blog

Both American Gut and British Gut welcome those who are currently healthy and those with medical conditions, both adults and children three months and older.  One does not need to be a U.S. or U.K. resident, but participants outside those countries may face high extra costs to ship their samples quickly and safely to one of the labs. Samples will be coded and personally identifying information will be protected according to standard research protocols and health privacy laws in the given countries.

Although this unconventional recruiting approach differs from standard, controlled clinical trials, these are legitimate research endeavors involving collaborations among scientists and social scientists associated with well-regarded academic, medical and scientific research institutions. Donated samples for American Gut will be received and coordinated by Dr. Knight’s lab at the University of California at San Diego, or British Gut samples by Prof. Spector’s lab at Kings College, London, but will also be used by researchers at more than two dozen sites in several countries.

It should be emphasized that although each team of researchers will provide participating donors with individual analyses of their own or their participating family members’ samples, and other reports about their research findings in general, the results are not intended to be, nor are they specific enough to guide prevention, diagnosis or treatment of IBS or any other medical condition. Scientific understanding of the human microbiome has not reached that point yet. While functional GI researchers and the updated 2014 American College of Gastroenterology guidelines on the treatment of IBS  (see the August  10, 2014 post) acknowledge that some people with IBS benefit from the use of probiotics, there are tens of thousands of individual strains and combinations of strains, only a handful of which have undergone clinical trials specifically with people with IBS. There is no way at this time for researchers and clinicians to target which ones may be helpful to a given individual with IBS. The microbiome studies in this post are not IBS-specific. They are broad, open source microbiome research of all people with and without known medical conditions who have volunteered themselves and  have not been selected by the researchers to control any particular demographic parameters. Readers of this blog post who choose to participate in American Gut, British Gut, or Australian Gut  should do so in the spirit of the public good and future understanding of how the microbiome works and influences human health. With that in mind, these are very interesting opportunities, and IBS Impact wishes all the involved researchers continued useful insights and progress toward those ends.


In-Person Support for Irritable Bowel Syndrome (IBS) in the United Kingdom

January 21, 2015

After the most recent post on this blog about the relative dearth of support and education options for people with IBS in their own communities (See the January 12, 2015 post), we were contacted by the IBS Network, the national charity for IBS in the United Kingdom. It was communicated that the organization does have existing self-help groups in a few locations, and is interested in starting more in other cities in the U.K., preferably with a volunteer who has IBS in each location to help coordinate the group. The IBS Network will provide information and advice as to how to start a new group.

For those residents of the U.K. who feel they might prefer or benefit from local support rather than the many Internet groups, please see the IBS Network’s self help group page for more information and contact details.

IBS Impact advocates a range of options to educate and support people with IBS and their families, wishes the IBS Network success in these endeavors, and hopes that gastrointestinal organizations, medical facilities and community groups in other nations will follow suit with similar efforts. Once again, readers of this blog are encouraged to comment with available resources or to discuss possible systemic barriers that people with IBS may face in getting access to community services and support.


Why Are Community-Based Education and Support for IBS So Hard to Find?

January 12, 2015

In many communities, at least in the United States, it is very common for a person recently diagnosed with, for example, diabetes or kidney disease, to be promptly referred to some sort of seminar or ongoing class designed to educate the person on his or her medical condition and appropriate management. Very often, these educational opportunities include some form of a support group. In other locations, some hospitals or clinics have nurses or other health educators available for affected people to call for quick questions between follow-up visits to one’s physician. That sort of thing seems unheard of for irritable bowel syndrome, even in major metropolitan areas that are rich with health and social service organizations of many sorts, even though diabetes and kidney disease, as prevalent as they are, are each individually less so than IBS.

One might say that diabetes and kidney disease are life-threatening conditions, each with many potentially serious complications if left improperly managed, while IBS is not. However, Down syndrome is not such a condition, and in that community, following the lead of one local DS parent group several decades ago, many DS parent groups nationwide have a service whereby experienced parent volunteers are available on request to meet with a new family for peer support and quality information mere hours after the birth or prenatal diagnosis. For many common disabilities and health conditions, support and information in one’s own town or city or nearby local areas can be found easily on the Internet or by referral from one’s health care facility or a local human service agency. Publicity of such resources in the media or community newsletters and electronic listservs often indirectly increases public awareness of a given disability or medical condition as well. These are good opportunities and often lead to better outcomes for affected people and families.

This availability of local, community-based programs is not generally the case for irritable bowel syndrome. There are many support forums on the Internet, some long established for years, some newer, many using anonymous user names, some with real names.  These play an important role for individuals with IBS and the IBS community as a whole, giving people with IBS access to peers all over the world. Several people involved with IBS Impact, in the present or past, have been founders or moderators of various such forums. As for evidence-based IBS education, as often publicized on this blog, the University of North Carolina Center for Functional GI and Motility Disorders, in particular, has been a pioneer in creating opportunities for state of the science patient education through its past online patient symposia, “Expert Updates” and past chat series and downloadable handouts that reach people in U.S. states and countries far beyond its Chapel Hill, North Carolina campus. This is all urgently needed and appreciated. But even two decades after increasingly widespread use of the Internet, not everyone is comfortable with technology or with such public forums with strangers, or may have other reasons for desiring or responding better to in-person education and support.

Why are Internet resources the only option in most cases? Why do the same basic questions and misconceptions about IBS come up repeatedly, sometimes daily or several times a day, not necessarily from people who have recently been diagnosed, but also from those who have already lived with diagnosed IBS for several years? Have they all been provided with excellent information from their health care providers, but simply do not have the willingness or capacity to listen and learn? Perhaps this is true for a subset, but that cannot be the case for all people with IBS who frequent one or more of these online support forums. Why are people with IBS so frequently left to their own devices in front of a computer, desperately typing into search engines, trying to sort through what is reputable and what is quackery, and asking questions of mostly layperson strangers, sometimes anonymous ones, on the other side of cyberspace when some of these answers clearly are so specific to the person’s individual situation or technical enough that they should come from the person’s own physician? Evidence-based research of all sorts shows that overall, IBS is astonishingly hard on the quality of life of people with significant IBS, on families and on society as affected people commonly go from health care provider to health care provider searching for answers, or deal with decreased productivity at work or school. Evidence also shows that those people with IBS who have good doctor-patient relationships tend to have better outcomes. Logically, it would be in everyone’s interests if people with IBS and the family members and friends who support them in their daily life were encouraged and given access to convenient, quality resources as soon as possible.

More than one person with IBS, when requesting a referral from a health care provider, human service professional or support group clearinghouse has been met with the bemused response, “There isn’t one.” or “Nobody else has ever asked.” Really? Anyone who has been in the IBS community for some time is aware that many people with severe IBS are afraid to go out unless absolutely necessary because of unpredictable and embarrassing symptom flare-ups. That also may be part of the answer, but people with inflammatory bowel disease and/or ostomy devices share some of the same concerns and it’s generally much easier to find local, in-person support groups for either of those conditions, which are also statistically much less common than IBS. Professionals and people with IBS  also often speak of the stigma of IBS that leads many people with IBS to delay or avoid asking for help altogether. Still, some of that increased stigma appears to be perception rather than reality, as people with similarly poorly understood, invisible chronic pain conditions or mental illness often have very similar complaints about how they perceive themselves to be regarded by others, and there are generally support groups for many of those conditions. Clearly, people with IBS need education and support as they flood the Internet forums by the thousands, with several new requests for membership every few hours in one busy multinational group.

So why, really, do we not have plentiful support and evidence-based education near our own homes, schools, workplaces, health care facilities, or community gathering places offered routinely from the moment of diagnosis or upon request?  Readers are invited to comment.  People with IBS, is there a support group or IBS education program near you? If not, have you asked for one? If you had a choice, would you prefer a community-based option or the Internet and why? IBS professionals and peer facilitators with IBS, do you have or have you tried local education and support? What has made any efforts succeed or fail, and what can we do as a community to begin to change the status quo in this respect? IBS Impact supports a range of options so that different individuals can choose the means that best fit their personal needs and desires at any given time.


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