Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00179582
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS

Condition or Disease	Intervention/Treatment	Phase
IBS	Drug: VSL#3	N/A

Detailed Description

The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
• Actual Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. Global improvement in IBS symptoms []

Secondary Outcome Measures

1. Frequency of bowel movements []

2. Changes in abdominal pain []

3. Changes in bloating []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• IBS diarrhea

Exclusion Criteria:

• < 18 years of age

• Pregnancy/breast feeding

• concomitant medications to reduce bowel function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BIDMC	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Anthony Lembo, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00179582
• Other Study ID Numbers: 2004P000001; VSL1
• First Posted: Sep 16, 2005
• Last Update Posted: Feb 27, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center: IBS; Functional bowel disorder; Diarrhea; probiotic
• Additional relevant MeSH terms: Diarrhea

Study Results

No Results Posted as of Feb 27, 2019