Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, irritable bowel syndrome, abdominal pain, urgency, bloating, diarrhea Read More

Inclusion Criteria:

• 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 Criteria:

• 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