Clinical Trials: Open Studies for Irritable Bowel Syndrome (IBS) in the U.S and U.K. May 2014

May 29, 2014

Below are two studies that have come to the attention of IBS Impact recently. The description below is a summary of major qualifications and details available, and other restrictions may apply.  If interested, please contact each listed sponsor directly for further information.

RESTORE 5 Study at the University of North Carolina Center for Functional GI and Motility Disorders, Chapel Hill, North Carolina

Women with IBS with diarrhea (IBS-D) ages 18-65 who are not pregnant, and do not have Crohn’s, colitis, diabetes mellitus, lactose intolerance, any other type of malabsorption, or celiac disease. Time commitment 8 weeks, 5 visits to UNC. There is monetary compensation (amount not specified.) http://www.ibsstudy.com/

The above listing was received from UNC Center social media and summarized from the study website.

***

Online Study on the Effect of Expressive Writing on IBS Symptoms, Royal Holloway University of London, United Kingdom.

This study is being conducted by a Royal Holloway University psychology PhD student, Hannah Bowers. She is seeking responses from  adults over 18 with IBS There does not appear to be a country restriction. The study involves online submission of writing samples  of approximately 500-100o words per entry twice a week for two weeks, and then at a 3 month followup according to guidelines provided by the study.  You must provide an email address to receive instructions during the study, but do not have to provide your name. Participants completing the study will have the option to enter a drawing for prizes worth up to 50 pounds. Contact information for Ms. Bowers and her RHUL supervisor and a consent form can be found at the link below.

http://edu.surveygizmo.com/s3/1621627/Does-writing-regular-journal-entries-affect-digestive-symptoms

The above listing was summarized from an email received directly from Ms. Bowers, as well as from the survey itself.

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 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.


Representative Brooks of Alabama Co-Sponsors HR 842 for Functional Gastrointestinal and Motility Disorders

May 21, 2014

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, Representative Mo Brooks (R-AL-5) has recently signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2013.

Representative Brooks is currently serving his second term in Congress. He represents Alabama’s 5th District,  which encompasses Colbert, Jackson, Lauderdale, Lawrence, Limestone, and Madison Counties, and a portion of Morgan County. Major cities within the district include Florence, Athens, Decatur, Huntsville and Scottsboro. According to Representative Brooks’ official House website, he is a member of the Armed Services Committee, and  has a record of supporting 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 Brooks, please take a few minutes to write or call him with your thanks for his support of HR 842 and the functional gastrointestinal and motility disorders community.

In officially supporting HR 842, Representative Brooks 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),  Representative Peter Welch (D-VT), Representative James McGovern (D-MA-2), Representative Gerald Connolly (D-VA-11), Representative Louise Slaughter (D-NY-25), Representative Bill Posey (R-FL-8), and Representative Ed Perlmutter (D-C0-7), Representative Jim Himes (D-CT-4) and Representative André Carson (D-IN-7). U.S. citizens residing in the districts of Representative Brooks’ colleagues listed here, please thank them as well.

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 Carson of Indiana Co-Sponsors HR 842 for Functional Gastrointestinal and Motility Disorders

May 14, 2014

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, Representative André Carson  (D-IN-7) has recently signed on as a co-sponsor to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2013.

Representative Carson, who was first elected the House of Representatives in an special election in 2008, is now serving his third full term in Congress. He represents Indiana’s 7th District in the central part of the state, which encompasses most of Marion County and the city of Indianapolis. According to Representative Carson’s official House website,  he currently holds the position of senior Democratic whip and is a member of the Armed Services Committee, and  has a record of supporting health care and 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 Carson, please take a few minutes to write or call him with your thanks for his support of HR 842 and the functional gastrointestinal and motility disorders community.

In officially supporting HR 842, Representative Carson 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),  Representative Peter Welch (D-VT), Representative James McGovern (D-MA-2), Representative Gerald Connolly (D-VA-11), Representative Louise Slaughter (D-NY-25), Representative Bill Posey (R-FL-8), and Representative Ed Perlmutter (D-C0-7) and Representative Jim Himes (D-CT-4)  U.S. citizens residing in the districts of Representative Carson’s colleagues listed here, please thank them as well.

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.


Guest Post: I Know Why People Can’t Tell I Have IBS. (Becoming More Present At Work)

May 5, 2014

This week’s guest blogger is Marcy Epstein, PhD. She has IBS and other disabilities and wrote this article especially for IBS Impact. For over 25 years, she has held varied positions as an educator, national public speaker, published author of five books and numerous articles, editor, publisher, disability scholar and advocate. She received her PhD in English Language and Literature with a post-doctoral specialization in disability research and rehabilitative psychology from the University of Michigan–Ann Arbor/U.S. Dept. of Education NIDRR Fellowship for Advanced Research and is currently Principal Consultant at Ann Arbor Educational Associates, working with individuals, groups and organizations in Southeast Michigan to support lifelong learning in children and adults, literacy, diversity, educational accessibility and equity. One particular interest of hers is “the complex roles that stress and trauma play in literacy and learning.” All of her diverse personal and professional experiences give her unique perspectives on living and working with IBS that we thank her for sharing with our readers. Dr. Epstein can be contacted directly at http://annarboreducationa.wix.com/home

 

 

 

irritableowl

I had intended a French epigram for which I wouldn’t need to beg the reader’s pardon, and yet the cartoon above really says more about the interior of many people with Irritable Bowel Syndrome (IBS) than a thousand bon mots. It is not just that there really is not an extant body for humor for Irritable Bowel Syndrome. It takes a lot of work to make IBS funny. I like the cartoon because it is pithy and punny: people rarely tell when we have IBS, unless we tell them. Worse, rarely do we feel we can tell them. Worse still, we fantasize about telling them off. Ergo, irritable owls. Ergo, this introduction.

I have always wondered how, despite displaying to them what feels to me like an obviously disturbed interior, other people never guess that I have IBS. They excuse my body’s irritability with social and moral irritability: to them, I am moody or even dark, disappointed in love or work, driven senseless by the elder or the younger, or even menopausal. When I fart like foul bagpipes, they politely blame the dog. If I disappear into the bathroom for an hour, someone will kindly attribute literariness to me, observing once that I was likely off reading Babette’s Feast on the pot (au contraire!) Incredible, I hoot inwardly. How can they not notice?

Fifteen years after diagnosis with IBS, getting used to the invisibility as much as the next cussing owl, I am considerably more pleasant and serious about our condition. IBS is complex, with very limited definition medically and legally as a chronic or conditional disability. It is represented in a constellation of symptoms felt in the core of our bodies, affecting every one of our functions, not particularly visible but not invisible either, if you know how to look for it. IBS is a bit like our owl that haunts and sleeps periodically. Painful, potentially isolating, potentially threatening, IBS can seem predatory on daily lives and relationships.

Our condition joins colitis, Crohn’s Disease, and other gastrointestinal and motility disorders in both the degree of pain and discomfort we experience and in the sensitive nature of sharing our discomfort. Would we talk about our bowels if they weren’t a clear source of pathos for us?

Once upon a time, I couldn’t care less about my insides. I was one of the Iron Guts, coated with extra hot sauce and beer. Things changed for me quickly after I broke my neck in 1997, incurring some spinal cord compression with a host of neurological symptoms from tingling pain, weakness, anxiety, to irritable bowel syndrome. I wrote in my essay for Deep: Real Life with Spinal Cord Injury (U. Michigan: 2006) that I barely understood my own disability until I lay in my own uncontrollable filth in an Israeli hospital, waiting for a stranger to see and respond to my distress. In the first years after injury, as I began teaching, my ailments were pretty obvious, but again, mostly because people interpreted cues other than my condition, qualities more dignifying of me, I supposed, but misleading. I looked like a banged up car with my labored gait, smelly collar, and furrowed brow. I could fall to tears and/or lose continence at any moment. Transitions to and from my office took hours, and I couldn’t distinguish if I was too anxious or too neurogenic or simply constipated from stress. I came to see all of these as interrelated, but I couldn’t see the relationship itself.

Here was the rub: my IBS was invisible to myself. For two years I fought the diagnosis, simply because it seemed like the easy way out for my doctors to tell me I was too anxious or hypochondriac. A syndrome isn’t exactly locatable or treatable. I wanted direction: take this pill, rest for two days, avoid hot sauce and beer. My physician explained the syndrome, smiling through the pronunciation of the words, as though IBS weren’t real, really, but just something to explain what he could not otherwise explain.

In my particular case, how to handle this “syndrome,” IBS, when I am at work was subsumed into treatment for my anxiety. I stayed in the environment of work because I had to survive, and, like you, I require purpose. But I had to switch gears in my profession as a college professor, to accept that my condition—a mix of privileged and disabled—was not going to be a popular issue with me or with my colleagues. As my gut suffered, so went the rest of me: I needed surgery after surgery, my immunity to illness and to self-blame plunged, and my work ethic bowed under pressure. Teaching felt more Herculean than ever, physically and emotionally. As my career slowly suffered from my mood, weight fluctuations, anxiety, and physical discomfort, I lost certain necessary ways of working with others and gained other intrepid ways to think intestinally. It slowly dawned on me that the syndrome I was resisting was real, indeed realer than our culture is prepared to encounter. So it was no surprise to me that I didn’t want to encounter myself either. I wanted to meet the world, not my own insides. Between IBS and several hernias, I really wanted my insides to stay inside, and the outside world to stay outside.

Bowels are definitive of organic life, yet anything that suggests evacuation of our waste seems adversely indicated in civilized society. The more advanced our world becomes, the more alienated we grow from our own insides. So to speak of our irritable bowels—with our families, communities, or workplace—represents a challenge to sensitivity. The reinforced invisibility of IBS—that we both don’t show our condition nor do people acknowledge any sign of it– means that there is nothing for people to stare at or ponder or pity. The syndrome is minutely visible, the real conjecture from the swollen curves of our bellies or maybe how we hold our bodies as we manage pain. I wonder if the sensitivity works both ways, not just to oppress us but to preserve us within our culture of work: I’m not sure I would like it if people knew every time I were having a shutdown of my system or just having the experience of pain. Not only would I feel too visible as an object of people’s discomfort about bowels, but also it could slow down my productivity. There would be the exhaustion of bowel distress and its explanation.

But I do not kid myself that I am completely invisible with my IBS and remember that the effects of IBS are being felt indirectly in the social construction of my work. My condition may be invisible, but my behavior around the condition is perfectly visible. My peers cannot be that thick as not to miss me for the twenty minutes I am writing in the restroom. They may substitute a reason, but I am not at my desk. The drained, anguished look like we’ve just had something terrible at lunch sticks out a bit more at three, four, and five o’clock. The pharmacopia of anti-spasmodics and Maalox on my dresser and in my bathroom pretty much tells guests that something’s amiss in the mesentery.

IBS shapes my work life even as it disrupts it. You see, like most people with IBS, I keep working with the great majority of my symptoms. When I can finally leave my own bathroom, I get to my first appointment. When I have spasms and bloating, I breathe carefully through the pain, visualize with humor that I am still with the majority, if I count the billions of microorganisms inside. I take sick days off when I cannot think because of the pain and exhaustion.

Leong et al (2003; reprinted in JAMA/Archives of Internal Medicine) produced a retrospective analysis of administrative claims data dating back roughly twenty years: “Results of the 1993 US householder survey² indicated that patients with IBS missed about 3 times as many days from work or school annually as people with no evidence of a functional GI disorder (mean, 13.4 vs 4.9 days; P = .001). More patients with IBS (11.3%) reported that they were often too sick to work or to attend school compared with those without IBS (4.2%).² More recent survey data (1999) indicate that the actual number of missed or shortened workdays due to IBS has increased even higher since the early 1990s.”¹¹

This research bodes ill for the IBS community in a world of work that is perfecting the worker, with employers in search of employees who never miss a day of work, who can remain all day in classrooms, factory floors, or offices, whose use of short- or long-term disability is most unlikely. In short, the truth about how IBS affects us can imperil our employability.

Assuming you are working (since paid or unpaid, most of us are raising children, volunteering, holding down one job or another), there is the second dimension of IBS and working that is more germane to my experience, and that is how to endure at work, building a balance between the perfectionism of the worker and the imperfection of a major body system. One term that Leong et al use that may help represent the experience of many people working while managing IBS is absenteeism v. “presenteeism”. Presenteeism is a powerful term. It suggests presence but with consideration, the problem not of staying away from work but of staying with it.

In that spirit, I conclude this writing with a practical list to help dispel the stigma attached to IBS and build instead a presence as productive survivalists, a presenteeism that isn’t posed as an HR problem as much as a possibility.

1. Consider shared spaces. Nina Pan wrote earlier this month in this blog that “[h]aving IBS is often an isolating experience, and some people with IBS who have ‘come out of the closet’ have found that the stress of hiding and worrying about who knew and how much they knew actually triggered worse symptoms. No, not everyone will ‘get it’ and that can be hurtful or tiring, but people without IBS will never learn to understand unless we are willing to tell them. Some of them will help you and it may be the people you least expect.” If you are invisible at your place of employ, start creating some incremental visibility. Identify a co-worker and create a “mind-body friendship” with them, one informed by what is going on in your body, good days and bad. If you are already visible, create positive contexts for interactions around your IBS, supportive notes or even some apropos humor to relieve the strain, so to speak.

2. Talk with colleagues more, complain less. This can be tricky, given how exhausting and painful IBS can be at times, but embrace the principle of professionalism of deflecting intense attention to IBS outbursts (except in medical emergencies). If you are in a difficult place with your IBS, deflect as much drama as you can. Instead, choose a time of calm in which to draw others into an understanding of what is happening for you, including the incident that recently occurred.

3. Protect your rights. If IBS disrupts major functions at work, and you can document this with your physician, then navigate the stormy channels of disability rights carefully. For example, disclose your functional accommodations at hiring, not the interview. I have not seen bowel motility work often as an icebreaker for employment. Make certain the accommodations you request are tailored to your IBS rather than the IBS of psychiatric history. Be reasonable and friendly, and you will not only expand your legal status but those of our allies. Most employers need IBS education, and unfortunately, without your education of them, your rights may be as inaccessible as the bathroom in the next building.

4. Take care of yourself at work. This principle cannot be overemphasized. Respecting yourself at work breeds respect from others. Caring for yourself at work sends the message that the shared space of work is rich with real life and that you are capable of embracing your work purpose, with a bit of help or understanding here and there. I cannot prescribe what caring for yourself at work means for you. For me, it means a locked drawer with medications, water bottle, honey candies, a picture of my dog, a pacifying note from a kind student, a book to read at lunch, and a bit of mad money. I used to keep extra undies in there, but nothing too sexy.

5. Use online support from the IBS community. Some days, people are just not going to get it. Join the Facebook IBS presence and other chat rooms for people struggling at work, and again, avoid the obvious pitfall of complaining about co-workers or workplace policies. Stick with communicating about your condition and state of mind, but be careful about demonstrating any incompetency relating to your work responsibilities, anything that might be inflammatory enough to risk job security. That said, you are not alone. When colleagues don’t suffice, find people of like minds and gastrointestinal tracts.

Since we have ended IBS Awareness Month, it would be good to tell our peers soon that we are alongside them at work and perhaps also to deepen our own awareness of IBS. Let’s not disappear because our month is over. I offer these next and last two ideas as radical forms of presenteeism, meant for those who feel the tug in their guts of not being fully present at work because we aren’t making ourselves visible:

6. Offer your workplace (using your HR as appropriate) training on Presenteeism. Think broadly about how IBS shares issues particular to your line of work with other conditions such as Crohn’s Disease, pregnancy, hypoglycemia, or diabetes. Publicize IBS Awareness Month. It is unwise to promote employer micro-micromanagement into how we account for our work-product while present at work each hour of each day (nothing like being responsible for the erosion of labor rights), but talking about how to adapt your workplace toward maximum efficiency and satisfaction (emphasizing employee self-regulation) can make you a model of excellence with IBS, not despite it.

7. Think of yourself differently while functioning with IBS. Unlike other potentially disabling conditions, IBS can strike hard at our bodies, minds, and paychecks. Socially invisible, our condition may be somewhat reified as an odd complaint. However, I would argue that a significant component of our complaint is not nervous, spastic, or such. Our complaint as we manage IBS at work is that we are little understood and yet caught up in a labor environment generally unsympathetic to imperfect workers. Forget the owl. See yourself as the canary in the proverbial mineshaft, but don’t pass out from social and professional toxicity. We with IBS indicate at work the oft-immeasurable properties of understanding of difference, teamwork, and adaptability. We feel it in our guts. Don’t deny the canary’s delicacy or subdue yourself to employment perfectionism. Instead, sing or fly. Remember Maya Angelou’s words from “I Know Why the Caged Bird Sings”:

The free bird thinks of another breeze
and the trade winds soft through the sighing trees
and the fat worms waiting on a dawn-bright lawn
and he names the sky his own.

Though watch out for those fatty worms.

Full text of “The Economic Consequences of Irritable Bowel Syndrome” is available at http://archinte.jamanetwork.com/article.aspx?articleid=215426#METHODS