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

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