Comparing the Effectiveness of 2 Diets for Patients With Irritable Bowel Syndrome

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. The study will also measure the effect of these diets on the bowel flora, which are the good bacteria that inhabit the bowels in healthy people.

Key facts

Study ID

NCT01624610

Run by

University of Michigan

People needed

100

Starts

2012-07-01

Expected to finish

2015-11-01

Last updated by the study team

2016-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet Rome III criteria for IBS as assessed by a gastroenterologist:
• Fulfill the Rome III stool consistency criteria for IBS -D
• Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie Loperamide 2mg up to 4 times per day prn diarrhea)
• Ability to provide written informed consent for study participation
• Capable of independently completing all requirements of the study including returning for required visits
• Documentation of normal colonoscopy with colon biopsies within five years
• Documentation of normal TSH, CBC, electrolyte panel
• Negative evaluation for celiac disease either with normal TTG, EMA, and/or duodenal biopsy.

You may not qualify if…

• Unable to understand or provide written informed consent
• Pregnancy
• IBS with constipation or mixed subtype
• Comorbid medical problems that may affect gastrointestinal transit or motility:
• Inflammatory bowel disease
• Extraintestinal disease known to affect the gastrointestinal system (ie, scleroderma, unstable thyroid disease, diabetes mellitus, etc.)
• Severe renal or hepatic disease
• Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery
• Previous treatment with some diets for IBS
• Concurrent medications not permitted including probiotics, antibiotics, and narcotics
• Active participation in another form of dietary therapy
• Patients who have undergone surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.