Status:
COMPLETED
Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Entera Health, Inc
Conditions:
Diarrhea Predominant Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 wi...
Detailed Description
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11%. IBS manifests itself in 3 major forms; diarrhea-predominant (IBS-D), constipation-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02251483
Start Date
September 1 2014
End Date
July 1 2015
Last Update
July 29 2015
Active Locations (1)
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1
GI Motility Program Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048