CompletedNot Applicable

Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth

United States2 participantsStarted 2014-09

Plain-language summary

The primary objective of this study is to determine whether giving SBI as a medical food starting with maintenance of health in the management of chronic loose and frequent stools in IBS-D subjects with SIBO after successful treatment with rifaximin can lead to more prolonged duration of benefit and delay symptom recurrence. SBI is the main ingredient in EnteraGam™, an orally administered prescription medical food for the dietary management of patients with enteropathy or chronic loose or frequent stools, including patients with IBS-D.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female aged 18-75 years old * Meet Rome II criteria for IBS-D * Meet criteria for SIBO * If ≥50 years old, a colonoscopy must have been completed within the past 10 years * Have just completed a course of antibiotic treatment with rifaximin and successfully responded to this treatment. Exclusion Criteria: * Had intestinal surgery (except appendectomy or cholecystectomy) * Pelvic floor dysfunction * Pregnancy or nursing mothers * History of bowel obstruction * History of celiac disease * History of inflammatory bowel disease * Cirrhosis * Diabetes * Use of tricyclic antidepressants * Use of antidiarrheal medications * Allergy or hypersensitivity to beef or any component of SBI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin

Timeframe: up to 4 months

Trial details

NCT IDNCT02251483

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Diarrhea Predominant Irritable Bowel Syndrome trials