Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

Completed · Phase 1

Conditions studied: Irritable Bowel Syndrome

In brief

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.

Key facts

Study ID

NCT00971711

Run by

Baylor College of Medicine

People needed

21

Starts

2009-09-01

Expected to finish

2013-12-01

Last updated by the study team

2016-03-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor Clinic — Houston, Texas, United States
• Univerisity of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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