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Irritable Bowel Syndrome (IBS)

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A 26-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C)

IRB# HUM00116173

Purpose

This study will compare the safety and effectiveness of an investigational drug for IBS-C.

Description

The study is seeking adults with IBS-C whose abdominal discomfort and constipation 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 the study drug tenapanor or placebo. Treatment lasts 26 weeks. In addition, clinical blood tests, EKG, physical examination, and vitals will be collected before and after randomization.

For each subject, the entire study will last 28 weeks; this includes 26 weeks of treatment, preceded by a 2-week screening period. It will require a total of 9 visits.

The proposed mechanism of action of tenapanor is to reduce Na+ re-uptake. This decrease in Na+ uptake increases the net fluid volume in the gastrointestinal tract. Restoration of normal luminal fluid content facilitates intestinal transit and stimulates motility.

Subject Eligibility

Compensation: $75 for each completed visit; a total of $675

Expected Recruitment End Date: November 2016

Principal Investigator: William Chey, MD

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


Probe-based confocal laser endomicroscopy to detect structural and functional duodenal mucosal abnormalities in patients with functional dyspepsia (FD): Understanding the mechanisms generating symptoms in functional dyspepsia

IRB# HUM00112343

Purpose

The lining of the small bowel will be evaluated at microscopic level in individuals with symptomatic functional dyspepsia (FD) and healthy individuals without gastrointestinal symptoms using the confocal laser endomicroscopy (CLE) technique, which is applied through a routine upper endoscopy (esophagogastroduodenoscopy [EGD]). CLE is a new technique capable of dynamic visualization of architectural changes of the gut mucosa at a microscopic level.

Description

The study is seeking two types of participants: FD group and healthy subjects group. Study will require 2 visits over a period of 2 to 4 weeks. First visit subjects will be screened to determine eligibility and consent. Participants with FD will go through a 2-week screening period, during which the severity of their dyspeptic symptoms will be assessed and eligibility determined. All eligible subjects will undergo an EGD with CLE on visit 2. Healthy subjects will have the EGD procedure at no cost to them, but FD subjects will be responsible for the EGD procedure charges.

Subject Eligibility

Healthy subjects must have no current or past history of gastrointestinal disease.

FD subjects must have at least one of the following symptoms of indigestion for at least 6 months duration:

Compensation: $100

Expected Recruitment End Date: November 2017

Principal Investigator: Borko Nojkov, MD

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


A study to compare the use of two different diets to reduce or improve loose stools or bowel incontinence

IRB# HUM00079064

Purpose

This study will compare two diets to see which one is more effective in improving or eliminating accidental bowel leakage (which is also called fecal incontinence). One diet is using foods that are low in fermentable carbohydrates and the other diet is using foods high in fiber.

Description

Study patients will be in the study for six weeks and will be expected to come to the investigator’s office for 4 visits, each visit lasting 1-2 hours.  Subjects will be asked to record symptoms daily during the 6 weeks. This will take approximately 5 minutes per day. Patients will be given dietary counseling for 4 weeks to asses if diet can help control the symptoms they are experiencing.

Responsibilities as a study patient will include the following:

The first two weeks, study patients will record symptoms daily to see if they will qualify for the study. The last 4 weeks, patients will be on the study diet and will record symptoms daily.

At the end of the study, study patients will be offered additional diet counseling for the alternate diet.

Follow-up survey (optional)

Subject Eligibility

This study is looking for patients who are experiencing fecal incontinence, bowel leakage, loose stool or other issues of bowel control.

Compensation: $120

Expected Recruitment End Date: December 2017

Principal Investigator: Stacy Menees, MD

Study Coordinator: Naoshin Khan email: naoshink@med.umich.edu, Telephone: (734) 936-1989