Use of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial Overgrowth
Use of Serum-derived Immunoglobulin/Protein Isolate (SBI) for the Maintenance of Health in Subjects With Irritable Bowel Syndrome (IBS) Following Successful Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
1 other identifier
interventional
2
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 17, 2014
CompletedFirst Posted
Study publicly available on registry
September 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 29, 2015
July 1, 2015
10 months
September 17, 2014
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to relapse (symptom recurrence) in subjects with IBS-D after successful treatment with rifaximin
up to 4 months
Secondary Outcomes (3)
Change in symptoms based on comparison of baseline symptom questionnaire to weekly symptom questionnaires
baseline and weekly questionnaires for up to 4 months
Comparison of baseline Bristol stool score based on 7 day stool diary
last week of every month for up to 4 months
Comparison of KT ratios in plasma samples
up to 4 months
Study Arms (2)
SBI
OTHERGroup 1: SBI (N=30) - one packet daily
Placebo
PLACEBO COMPARATORGroup 2: Placebo (N=30) - one packet daily
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- Entera Health, Inccollaborator
Study Sites (1)
GI Motility Program Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, GI Motility Program
Study Record Dates
First Submitted
September 17, 2014
First Posted
September 29, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07