Irritable Bowel Syndrome (IBS)

Comparing two forms of dietary therapy to control the symptoms of irritable bowel syndrome with diarrhea (IBS-D): a randomized, controlled trial and gastrointestinal microbiome analysis

IRB# HUM00053274

Purpose

The study compares two diets that have been recommended for improving symptoms associated with IBS.

Description

The study is seeking adults with irritable bowel syndrome with diarrhea (IBS-D) whose abdominal discomfort and diarrhea are not well controlled. After a 2-week screening period, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to receive one of two diets: Diet 1 or Diet 2, to which they will adhere for 4 weeks. In addition, stool and blood samples will be collected before and after randomization to measure relevant biomarkers.

Subject Eligibility

• This study is seeking 18 years or older male and female patients with diarrhea-predominant IBS condition.
• Must NOT have constipation more than 25% of the time
• Female childbearing potential must not be pregnant
• Must not have inflammatory bowel disease (Crohn's disease, ulcerative colitis, microscopic colitis), pancreatitis, or Hirschsprung's disease, or prior bowel obstruction
• Must not have prior bowel resection (accepted is appendectomy, cholecystectomy, and polyp removal)
• Must not have uncontrolled diabetes or thyroid function, or have hepatitis, B or C, or HIV
• Must not have chronic kidney, heart, or lung disease that may prevent study completion.
• Must not have untreated cancer
• Must not take antibiotic, probiotic, or narcotic pain medication while in the study.

Compensation: $120

Expected Recruitment End Date: January 2014

Principal Investigator: Shanti Eswaran, MD

Study Coordinator: Lina E-mail: LNahlawi@med.umich.edu, Telephone: (734) 936-2761

A study to assess repeat treatment efficacy and safety of rifaximin 550 mg three times a day in subjects with irritable bowel syndrome with diarrhea (IBS-D)

IRB# HUM00062179

Purpose

The study is evaluating the use of rifaximin (an antibiotic) compared to placebo in the treatment of IBS-D. The purpose of this study is to determine if rifaximin is safe and helpful in treating IBS-D symptoms in patients who previously were helped by rifaximin treatment.

Description

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study in subjects with IBS-D. Approximately 1850 subjects at 250 clinics in the United States will take part in this research study. Participation ranges from as few as 30 weeks and up to 51 weeks. This study consists of 4 treatment phases and 2 maintenance treatment-free phases that will involve up to 9 visits to the research office and up to 7 additional telephone calls by the investigators. At the end of each phase the participant will be inform if they are eligible to continue into the next phase. A clinic visit will occur at the beginning of each phase. The Screening/Treatment 1 Phase may have 1 or 2 visits depending on if the participant will need a colonoscopy or not. Throughout these periods participants are required to make daily diary entries to answer questions about their IBS symptoms and bowel habits.

Subject Eligibility

• This study is seeking 18 years or older male and female patients with diarrhea-predominant IBS condition.
• Must NOT have constipation
• Female childbearing potential must not be pregnant or breastfeeding
• Must not have inflammatory bowel disease (Crohn's disease, ulcerative colitis, microscopic colitis), pancreatitis, or Hirschsprung's disease, or prior bowel obstruction
• Must not have prior bowel resection (accepted is appendectomy, cholecystectomy, and polyp removal)
• Must not have diabetes or thyroid dysfunction, or have hepatitis, B or C, or HIV
• Must not have chronic kidney, heart, or lung disease that may prevent study completion
• Must not have cancer
• Must not take certain medication while in the study

Expected Recruitment End Date: 2014

Principal Investigator: Richard J. Saad, MD

Study Coordinator: Lina E-mail: LNahlawi@med.umich.edu, Telephone: (734) 936-2761