Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00971711
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : March 8, 2016
National Institute of Nursing Research (NINR)
University of Washington
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Biological: Probiotic Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open Label Safety Study of VSL#3 in Adults With Irritable Bowel Syndrome
Study Start Date : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety [ Time Frame: Daily for 4 or 8 weeks of treatment and 1 month after treatment ]

Secondary Outcome Measures :
  1. Pain and Stooling Improvement [ Time Frame: 4 or 8 weeks of treatment and 1 month after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
National Institute of Nursing Research (NINR)
University of Washington
Principal Investigator: Robert J Shulman, M.D. Baylor College of Medicine

Additional Information:

Responsible Party: Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine Identifier: NCT00971711     History of Changes
Other Study ID Numbers: 24041
R01NR005337 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Robert Shulman, M.D., Baylor College of Medicine:
irritable bowel syndrome
abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases