Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
Completed · Not applicable · Has a placebo group
Conditions studied: Diarrhea Predominant Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
In brief
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.
Key facts
- Study ID
- NCT02251483
- Run by
- Cedars-Sinai Medical Center
- People needed
- 2
- Starts
- 2014-09-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-07-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- GI Motility Program Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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