Status:
COMPLETED
Safety Study of Probiotics in Adults With Irritable Bowel Syndrome
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
University of Washington
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.
Detailed Description
Recent studies performed outside the U.S. and/or prior to recent FDA requirements suggest that the probiotics in VSL#3 may be effective in IBS in adults. Because there is a significant unmet need for ...
Eligibility Criteria
Inclusion
- Otherwise well and meet the criteria for IBS as defined by the Rome III criteria
- Ability to speak and understand English
- Telephone access
- IBS Severity Scale score of \>= 75
Exclusion
- Organic disease accounting for GI symptoms.
- Chronic illness such as renal disease, congenital heart disease, diabetes, moderate or severe asthma, abdominal surgery, or immunosuppressed (e.g., organ transplant recipient).
- Have received extraneous probiotic (i.e., not in a food such as yogurt) within 4 months of starting the study.
- Subjects who are taking prescription or over-the-counter medications for GI disorders that completely relieve their symptoms because by definition these individuals do not have IBS (e.g., antacids, proton pump inhibitors, histamine receptor antagonists).
- Medication allergies or contraindications which would preclude antimicrobial treatment for potential infection with VSL#3 component organisms.
- Pregnancy.
- Subjects who have an individual in the household who is immunosuppressed (e.g., genetic immune disorder, organ transplant).
- Oral temperature \> 38.0 degrees Celsius.
- Poorly controlled hypertension, history of cardiac disease, stroke/cerebral vascular accident, bowel ischemia, or other risk factors for bowel ischemia.
- History of acute or chronic pancreatitis
- Cardiac valvular disease or other risk factor for endocarditis
- Subjects who indicate on the IBS scoring questionnaire that their pain is "severe" or "very severe."
- Subjects who pain lasts more than 5 out of 10 days.
- Subjects whose scores indicate more than mild IBS who are over 45 years of age
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00971711
Start Date
September 1 2009
End Date
December 1 2013
Last Update
March 8 2016
Active Locations (2)
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1
Baylor Clinic
Houston, Texas, United States, 77030
2
Univerisity of Washington
Seattle, Washington, United States