Health and Quality of Life in IBS Are About More Than an Irritable Bowel

June 25, 2013

Basic introductory materials on IBS aimed at people who are undiagnosed or newly diagnosed tend to have a positive tone. We are told that there is nothing visibly wrong with our digestive tracts, that we are not at particular risk for colon cancer, and yes, we may have abdominal pain, diarrhea, constipation, gas and/or bloating, but for many people, these symptoms are mild and/or sporadic. Such materials generally attempt to assure us that while there is no cure for IBS, with a few diet modifications, exercise and stress management, most of us will be just fine, and for those who are not, medications are available if we consult our doctors.

Most of the above description is likely true for the about 40% of people with IBS that a Rome Foundation Working Team Committee estimated in 2011 are mildly affected, and a portion of the 35% estimated to be moderately affected. That still leaves about 25% who can be classified as severely affected. (See the January 10, 2012 post.)  Given that IBS affects anywhere from 9-23% of the population in different countries worldwide, even that last subset alone is quite large. Those of us on the moderate to severe part of the spectrum who have lived with IBS for many months or many years understand that our reality is not as simple as the first paragraph would suggest. Any particular treatment intervention only helps some people, there’s no way to predict which ones will work or not for any specific individual, and even the most statistically effective options, like gut-directed hypnotherapy or cognitive behavioral therapy, aren’t always readily available or foolproof. Historically, most IBS treatment has focused on identifying and attempting to minimize whichever bowel symptom appears to be predominant or most bothersome.

As has been written on this blog several times in the past, including September 6, 2011 and March 11, 2013, irritable bowel syndrome isn’t even just about bowels for the approximately one-third of us who, according to Olafur Palsson, PsyD. of the University of North Carolina Center for Functional GI and Motility Disorders, experience significant non-GI symptoms or even larger percentages of overlapping medical conditions. Traditional or complementary health care, medications, supplements, special foods, extra personal hygiene items, books and CDs about IBS, etc. are all potential expenses that add up for the households of those with significant IBS. Some people with IBS are unable to continue their education or employment, and even those who are may find their productivity suffers, affecting colleagues, the employer and ultimately society. (See the March 19, 2012 post.)  Relationships with family and friends are also a common concern. (See the September 18, 2011 and  February 27, 2013 posts.)  None of this is news to medical and mental health professionals who specialize in functional gastrointestinal disorders like IBS and interact with the most significantly affected of us on a regular basis, but quantifying this for the larger community of gastroenterologists and other medical providers in various specialties is an important part of awareness. An interesting new study has recently been presented at the annual Digestive Disease Week conference for gastroenterology professionals in May 2013 that may become a step forward in that endeavor.

As Dr. Palsson reports on his own blog, FGID Update, in the post entitled, “DDW 2013 Note: Self-Perceived Poor Health in IBS is Mostly Due to Other Things Than Bowel Symptoms” he, as well as others who study or treat IBS or other chronic conditions, has sometimes observed striking discrepancies between the objective severity of symptoms and affected individuals’ self-reported state of health. In other words, some people with significant symptoms rate their health as excellent while others with seemingly fewer or less severe symptoms may state their health is poor.  According to Dr. Palsson, the new study, led by Jeffrey Lackner, PsyD of the University at Buffalo, State University of New York, and a team of many other researchers from Buffalo, Northwestern University in Chicago and Wayne State University in Detroit, Michigan, involved 235 adults with IBS. Participants were asked to complete detailed questionnaires on health, psychological symptoms, non-gastrointestinal physical symptoms, quality of life and social functioning. Dr. Lackner and his colleagues found that the actual severity of IBS symptoms, as measured on a standard scale used in most IBS research, had relatively little to do with how study participants perceived their own health. There were many possible variables involved,  but the strongest correlations with reported poor health in this specific study were fatigue,  somatization (high number of non-GI symptoms), negative social interactions and anxiety or depression. As Dr. Palsson seems to suggest, the results point toward both a need and an opportunity for medical professionals to shift focus when needed to address these issues with the people with IBS they affect. Some existing treatment options and educational approaches may help, and more attention to these issues in future research may lead to further advances in the years to come.

While the number of people in this study was relatively small, and, in a research context, cannot yet be considered definitive, the evidence appears to validate the experiences of both some functional gastrointestinal disorder professionals and some people with IBS , including the IBS Impact founder, on aspects that have historically received relatively scant attention. May the work of Dr. Lackner and his colleagues bring some hope and acknowledgement to others who may struggle with some or all of the issues addressed by this study. IBS Impact actively encourages awareness of many aspects of IBS, whether they are medical, psychological, social, financial or other, for this broad, multifaceted approach is likely the best chance for deep understanding of IBS-related needs and long-term societal changes in this regard.


Clinical Trial: New or Ongoing Studies for Irritable Bowel Syndrome (IBS) or Pediatric Chronic Abdominal Pain, June 2013

June 16, 2013

Below is a selection of studies that have come to the attention of IBS Impact through various sources in the last few months. In most cases, the description below is a summary of major qualifications and details available, and other restrictions may apply.  If interested, please contact each listed sponsor or study site directly for further information.

Online Survey on the Impact of IBS on Daily Life and Well-Being, Center for Psychosocial Research In GI at Northwestern University.

Conducted by Sarah Ballou, a clinical psychology doctoral student under the supervision of Laurie Keefer, PhD.

Adults ages 18-70 with IBS. Not eligible if you have inflammatory bowel disease (IBD) such as Crohn’s disease or ulcerative colitis, are currently pregnant or have given birth in the last 12 weeks.

Estimated completion time 20- 25 minutes. Demographic details (age, sex, race, education level, etc.) are asked, but not your name.  http://cprgi.org/announcements/do-you-have-ibs/  (Information from CPRGI’s social media and website)

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Phase III Rifaximin Re-Treatment Study for IBS with Diarrhea (IBS-D), sponsored by Salix Pharmaceuticals

Estimated enrollment of 800 adults at 250-300 study sites throughout the United States. Randomized and double blind, 550 mg. Rifaximin or placebo, three times daily for 7-14 days, plus followup, then re-treatment and followup for those who respond to the initial phase of treatment. Time commitment will vary depending on the response to treatment.

Open to men and women at least 18 years old with a confirmed Rome III criteria diagnosis of irritable bowel syndrome, colonoscopy within the last 10 years to rule out inflammatory bowel disease, willing to maintain a stable diet including vitamins and supplements.

Not eligible if you have diabetes, lactose intolerance not controlled by a lactose free diet, are pregnant, planning to become pregnant, lactating, have a history of HIV or hepatitis B or C,  have taken any antibiotic in the last 60 days or have participated in any other investigational study in the last 30 days.

Contact Rachel Ballard at rachel.ballard@salix.com or Alyson Lineberry at alyson.lineberry@salix.com (Information summarized by IBS Impact from IFFGD and the Salix Rifaximin re-treatment study listing on the ClinicalTrials.gov website.)

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Phase II Plecanitide Study for IBS with Constipation (IBS-C) sponsored by Synergy Pharmaceuticals

Estimated enrollment of 350 adults at over 60 study sites in many U.S. states. Participants will be assigned to groups for an oral daily medication of plecanitide at one of five different doses or placebo for 12 weeks.

Open to men and women ages 18-75 who meet Rome III criteria for IBS with constipation. Several other criteria and possible exclusions apply.

For more information, see the CIBS Study website. (Information summarized by IBS Impact from the CIBS Study Website and the Synergy plecanitide study listing on the Clinical Trials.gov website.)

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Mothers of Children ages 4-18 With or Without Chronic Abdominal Pain, Phone Study by the University of North Carolina

The UNC Center for Functional GI and Motility Disorders is seeking mothers of children ages 4-18 either with a physician diagnosis of functional abdominal pain, recurrent abdominal pain or IBS or mothers of children without chronic abdominal pain as a control group.

The study involves one phone interview with a study investigator about family medical history. This will be scheduled at a mutually convenient time and last 15 minutes to 1 hour depending on the complexity of your history.

The purpose is to study the possible role of low energy metabolism (mitochondrial dysfunction) in chronic pain conditions. There is some scientific evidence suggesting that this may be inherited from the mother’s side of the family.

Participants will be entered into a drawing for a $50 gift card, one for the chronic pain group and one for the control group.

For more information see the UNC pediatric abdominal pain study website or email abdominalpainstudy@unc.edu (Information summarized by IBS Impact from the above website and the Center’s Spring 2013 newsletter)

While IBS Impact attempts to highlight a diversity of available opportunities, this is not intended as an exhaustive list. 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. 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. 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.


Representative McGovern of Massachusetts Co-Sponsors HR 842 for Functional Gastrointestinal and Motility Disorders

June 9, 2013

UPDATE: 06/13/2015: HR 842 did not pass, but a similar bill, HR 2311, is currently in the House of Representatives for 2015-2016. Please click on the HR 2311 sub-category on the right sidebar of this blog to see the relevant posts.

According to THOMAS, the Library of Congress legislative database, and IFFGD/the Digestive Health Alliance,  on June 6, 2013, one day after Digestive Health Congressional Call-In Day, Representative James (Jim) McGovern (D-MA-2)  signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2013.

Representative McGovern is serving his ninth term as a member of the House of Representatives. He currently represents Massachusetts’ 2nd district in the central part of the state, including large portions of Worcester, Hampshire and Franklin Counties and small sections of Hampden and Norfolk Counties. According to Representative McGovern’s official House website, he has a record of supporting many pieces of legislation on health or veterans’ issues.  As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population.

If you are a constituent of Representative McGovern, please take a few minutes to write or call with your thanks for his support of HR 842 and the functional gastrointestinal and motility disorders community.

In officially supporting HR 842, Representative McGovern joins the lead sponsor, Representative F. James Sensenbrenner, Jr. (R-WI-5) and co-sponsors, Representative James Moran (D-VA-8), Representative Julia Brownley (D-CA-26), Representative Bobby Rush (D-IL-1),  Representative Gwen Moore (D-WI-5), Representative Ron Kind (D-WI-3), Representative Susan Davis (D-CA-53), and Representative Peter Welch (D-VT). U.S. citizens residing in the districts of Representative McGovern’s colleagues listed here, please thank them as well. Although Congressional Call-In Day is over for this year, ongoing advocacy for HR 842 needs to continue every day.

According to the information on THOMAS, it appears that the bill is currently under consideration in the Subcommittee on Health. Click on the link above if you would like to see a list of its members.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 842 and you have not contacted him or her recently to ask for his or her support, please see the previous post from March 2, 2013  for links to the bill and more details on how to do so.  Often, it takes multiple attempts to elicit any interest from legislators, so if you do not receive a reply, do not hesitate to try again or to switch contact methods until you attract attention. Keep in mind that your Representative may be different from before because of the 2012 elections, district boundaries that may have been re-drawn, or if you have moved.

Your personal experiences as a person with IBS and/or other functional GI/motility disorders, or as a concerned family member, friend or colleague, are most effective in communicating to legislators and their staff that there are real human beings behind the statistics. However, even general expressions of support are helpful.

HR 842 is bipartisan legislation (supported by members of both parties) and according to IFFGD discussions with IBS Impact,  is “revenue-neutral,” meaning that there will be no additional taxes or spending added to the current federal deficit if it is enacted. Discretionary funds are available at the National Institutes of Health to be allocated if Congress directs NIH, through this Act, that functional gastrointestinal and motility disorders are a priority. Congress will only do so if we, as a community, are able to show them the importance of the research, education and FDA coordination provided for in HR 842.

NIH grants funding to researchers throughout the world, not just in the U.S., so in the long run, enactment of this Act may also benefit readers with IBS in other countries. Medical research also sometimes involves multinational teams of scientists, and in any case, study results are usually published globally, adding to the cumulative knowledge worldwide.

It is IBS Impact’s understanding that HR 842 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 113th,  the necessary number of sponsor/cosponsors must be reached by December 2014. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 842 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012. While it is quite common for legislation of various sorts to take several Congresses to pass, our continuing advocacy now can increase awareness, build momentum and perhaps accelerate passage. It is in our hands.

Check back on this blog or join IBS Impact’s Facebook page or Twitter feed for further updates on HR 842 as they occur. Links to the social media sites can be found on the right sidebar of the blog.


Representative Welch of Vermont Co-Sponsors HR 842. Congressional Call-In Day for Functional Gastrointestinal and Motility Disorders is June 5, 2013

June 1, 2013

UPDATE: 06/13/2015: HR 842 did not pass, but a similar bill, HR 2311, is currently in the House of Representatives for 2015-2016. Please click on the HR 2311 sub-category on the right sidebar of this blog to see the relevant posts.

According to THOMAS, the Library of Congress legislative database, and IFFGD/the Digestive Health Alliance, as of mid-May 2013, Representative Peter Welch (D-VT) has signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2013.

Representative Welch is serving his fourth term as a member of the House of Representatives. He is the single, at-large representative in the House for the entire state of Vermont. According to Representative Welch’s official House website,  he is a member of several health-related caucuses within Congress, and. has a record of supporting many pieces of legislation on health or veterans’ issues.  As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population. Representative Welch was also the initial co-sponsor of H. Res 1309 for IBS awareness and research in the 111th Congress in 2010 and the previous version of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act, HR 2239 in the 112th Congress in 2011-2012.

If you are a constituent of Representative Welch, please take a few minutes to write or call with your thanks for his consistent and continuing support of HR 842 and the functional gastrointestinal and motility disorders community.

In officially supporting HR 842, Representative Welch joins the lead sponsor, Representative F. James Sensenbrenner, Jr. (R-WI-5) and co-sponsors, Representative James Moran (D-VA-8), Representative Julia Brownley (D-CA-26), Representative Bobby Rush (D-IL-1),  Representative Gwen Moore (D-WI-5), Representative Ron Kind (D-WI-3), and Representative Susan Davis (D-CA-53). U.S. citizens residing in the districts of Representative Welch’s colleagues listed here, please thank them as well.

IFFGD/the Digestive Health Alliance’s upcoming annual Congressional Call-In Day is an excellent opportunity for constituents of current supporters to express their appreciation to their legislators, as well as  forU.S. citizens whose Representatives are not yet co-sponsors to advocate for their support. This year’s Call-In Day is scheduled for this coming Wednesday, June 5, 2013. On that day IFFGD/DHA and other IBS sites, including IBS Impact, strongly encourage all U.S. citizens with all functional gastrointestinal or motility disorders (for example, irritable bowel syndrome, GERD, gastroparesis, chronic idiopathic psuedo-obstruction, Hirschsprung’s disease,  functional (recurrent) abdominal pain, cyclic vomiting syndrome, functional dyspepsia and many others, which collectively affect at least 25% of the population), concerned family members, friends, co-workers or classmates, health and human service professionals who work with people with functional GI or motility disorders, to call their Representatives about HR 842 on that date. A strong, unified presence by many voices on the same day will make an impression that will pave the way for the IFFGD/DHA’s delegation of self-advocates with functional GI or motility disorders and functional GI professionals who will travel to Washington, DC to advocate in person later this month on IFFGD/DHA Advocacy Day 2013.

If you know the member of the federal House of Representatives who represents you, the direct telephone number for his or her Washington, DC office can usually be found on his or her official website, which can be located by an Internet search of his or her name. Keep in mind that your Representative may be different from before because of the 2012 elections, district boundaries that may have been re-drawn, or if you have moved. If you are not sure who is your Representative, you can look up this information at  http://www.house.gov/representatives/find/ or call the U.S. Capitol switchboard at (202) 225-3121.

During business hours Eastern time on June 5, call your Representative’s office. Identify yourself as a constituent and give your name and the town or city in which you reside and ask to speak to the staff member who deals with health issues. You may be asked for your street address or phone number. This is to confirm that you do live in the Representative’s district and/or to allow the office to contact you to follow up. If you are nervous, in advance of calling, write down notes for yourself or a short presentation to read. You do not have to be an excellent speaker, just a person that the legislator and his or her staff will see as a real person with real needs. Be polite, keep the conversation on topic and limited to a few minutes, and thank the staff person for his or her time. Ask for the Representative to support HR 842 (or express your thanks for if he or she has already signed on).

Briefly explain your personal interest and/or experience with functional GI or motility disorders (for example, have had/family member has had irritable bowel syndrome for X years and has had difficulty finding appropriate treatment) and/or why functional GI and motility research and education provided for in HR 842 are important in general such as briefly what a functional GI or motility disorder or  your specific one of interest, like IBS,  is, how many people it affects, usually affects both genders, all ages, all ethnic groups  that IBS/functional GI disorders are usually chronic. often misdiagnosed or mistreated and effective treatments, providers and local community services are limited. Thank the staff member again before ending your call. If the staff member who deals with health issues is not available, leave a brief message with the above details on voice mail or with the staff member who answers the phone. It is rare for such advocacy calls to result in an immediate commitment to a particular bill, but one purpose of Call-In Day is to create awareness of the needs that affect large numbers of people and momentum for increasing Congressional support.

For more information on HR 842 and advocacy strategies, including links to the bill see the previous post from March 2, 2013 or click on the HR 842 category in the right sidebar of this blog to see all posts on this topic. Click the following link for  DHA’s page on Call In Day 2013.

IBS Impact urges all U.S. citizen readers of this blog to participate in the important and easy advocacy effort and to spread the word among your supportive relatives, friends and functional GI and motility disorder groups.  The progress of HR 842 is in our hands.

Check back on this blog or join IBS Impact’s Facebook page or Twitter feed for further updates on HR 842 as they occur. Links to the social media sites can be found on the right sidebar of the blog.