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

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179582
First Posted: September 16, 2005
Last Update Posted: March 6, 2017
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.
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center
September 13, 2005
September 16, 2005
March 6, 2017
January 2005
January 2006   (Final data collection date for primary outcome measure)
Global improvement in IBS symptoms
Same as current
Complete list of historical versions of study NCT00179582 on ClinicalTrials.gov Archive Site
  • Frequency of bowel movements
  • Changes in abdominal pain
  • Changes in bloating
Same as current
Not Provided
Not Provided
 
Dose Ranging Study With the Probiotic Combination (VSL#3) in Diarrhea IBS
A Randomized, Multi-center, Double-blind, Placebo Controlled, Dose Ranging Study With VSL#3 in Diarrhea Predominant IBS Patients
To evaluate the effects of VSL#3 on symptoms associated with diarrhea predominant IBS
The study will evaluate 2 doses of VSL#3 and placebo over a 4 week period in patients presenting with diarrhea predominant IBS symptoms.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
IBS
Drug: VSL#3
Not Provided
Niv E, Naftali T, Hallak R, Vaisman N. The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Dec;24(6):925-31. Epub 2005 Jul 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
180
January 2006
January 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • IBS diarrhea

Exclusion Criteria:

  • < 18 years of age
  • Pregnancy/breast feeding
  • concomitant medications to reduce bowel function
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00179582
2004P000001
VSL1
Not Provided
Not Provided
Not Provided
Anthony Lembo, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP