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 range18 Years – 75 Years

SexALL

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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

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