Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

This study has been completed.
University of Washington
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine Identifier:
First received: September 2, 2009
Last updated: May 12, 2014
Last verified: May 2014

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

Condition Intervention Phase
Irritable Bowel Syndrome
Biological: Probiotic
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Open Label Safety Study of VSL#3 in Adults With Irritable Bowel Syndrome

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Safety [ Time Frame: Daily for 4 or 8 weeks of treatment and 1 month after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain and Stooling Improvement [ Time Frame: 4 or 8 weeks of treatment and 1 month after treatment ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
To determine the safety and effectiveness of the probiotic VSL#3 in adults with irritable bowel syndrome (IBS).
Biological: Probiotic
The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.
Other Name: VSL#3

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 improved IBS therapies to prevent frequent exacerbations that lead to unscheduled health care, we will conduct a safety study of the probiotic VSL#3. Preliminary studies suggest that probiotics such as VSL#3 are effective in the treatment of adults with IBS but safety studies have not been carried out. A safety study of VSL#3 has been carried out in adult asthmatics that demonstrated no significant adverse effects. Before a trial of VSL#3 can be performed in children with IBS, the FDA has requested that a safety trial be conducted in adults with IBS.

Consent will be obtained from the subject.

Adults who meet the criteria for irritable bowel syndrome will be recruited and studied. They will have been diagnosed by an adult gastroenterologist.

During a baseline one week period, the subjects will keep a diary of pain episodes, pain severity, pain-induced interference with activity, and stooling pattern (i.e., pain/activity/stool diary).

Following the baseline period, the subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. During the treatment period, subjects will keep the diary for pain and stooling habits and a daily record of symptoms (i.e., daily temperature monitoring).

At the end of the treatment period the pain/stool/activity diary will be repeated. Four weeks after the treatment period ends a follow-up phone call will be made to participants to check on their pain and stooling patterns.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  • Live within 60 miles of the Texas Medical Center in Houston, Texas

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00971711

United States, Texas
Baylor Clinic
Houston, Texas, United States, 77030
United States, Washington
Univerisity of Washington
Seattle, Washington, United States
Sponsors and Collaborators
Baylor College of Medicine
University of Washington
Principal Investigator: Robert J Shulman, M.D. Baylor College of Medicine
  More Information

Additional Information:
Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care 2007;36:137-153.
Lane MM, Weidler EM, Czyzewski DI, Shulman RJ. Pain Symptoms and Stooling Patterns Do Not Drive Diagnostic Costs for Children with Functional Abdominal Pain and Irritable Bowel Syndrome in Primary or Tertiary Care. Pediatrics 2009;123:758-764
McOmber M, Shulman RJ. Pediatric Functional Gastrointestinal Disorders. Nutr Clin Prac 2008; 23: 268-274.

Responsible Party: Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine Identifier: NCT00971711     History of Changes
Other Study ID Numbers: 24041, R01NR005337, 005337
Study First Received: September 2, 2009
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
irritable bowel syndrome
abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases processed this record on March 31, 2015