Safety Study of Probiotics in Adults With Irritable Bowel Syndrome
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Purpose
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 |
- Safety [ Time Frame: Daily for 4 or 8 weeks of treatment and 1 month after treatment ] [ Designated as safety issue: Yes ]
- Pain and Stooling Improvement [ Time Frame: 4 or 8 weeks of treatment and 1 month after treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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.
Eligibility| 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| Contact: Erica W Baimbridge | 713-798-0381 | baimbrid@bcm.edu |
| United States, Texas | |
| Baylor Clinic | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Erica Baimbridge 713-798-0381 baimbrid@bcm.edu | |
| Sub-Investigator: Bincy Abraham, M.D. | |
| United States, Washington | |
| Univerisity of Washington | Not yet recruiting |
| Seattle, Washington, United States | |
| Principal Investigator: Margaret Heitkemper, Ph.D | |
| Principal Investigator: | Robert J Shulman, M.D. | Baylor College of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00971711 History of Changes |
| Other Study ID Numbers: | 24041, R01NR005337, 005337 |
| Study First Received: | September 2, 2009 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Baylor College of Medicine:
|
IBS irritable bowel syndrome abdominal pain |
urgency bloating diarrhea |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013