Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

March 4, 2016 updated by: Robert Shulman, M.D., Baylor College of Medicine

Phase I, Open Label Safety Study of VSL#3 in Adults With Irritable Bowel Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor Clinic
    • Washington
      • Seattle, Washington, United States
        • Univerisity of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • VSL#3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Daily for 4 or 8 weeks of treatment and 1 month after treatment
Daily for 4 or 8 weeks of treatment and 1 month after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain and Stooling Improvement
Time Frame: 4 or 8 weeks of treatment and 1 month after treatment
4 or 8 weeks of treatment and 1 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Institute of Nursing Research (NINR)
University of Washington

Investigators

  • Principal Investigator: Robert J Shulman, M.D., Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24041
  • R01NR005337 (U.S. NIH Grant/Contract)
  • 005337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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