Probiotics in Irritable Bowel Syndrome

This study has been withdrawn prior to enrollment.
(sponsor decided they are not interested in the study due to finacial reasons)
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00846170
First received: February 16, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

Probiotics are defined as 'mono- or mixed cultures of live micro-organisms which, when applied to animal or man, beneficially affect the host by improving the properties of the indigenous flora'. Certain probiotics possess potent antibacterial and antiviral properties. Probiotic antibacterial activity may derive from the direct secretion of bacteriocins, the elaboration of proteases directed against bacterial toxins or through their ability to adhere to epithelial cells and thus exclude pathogens. The antiviral properties of some probiotic organisms, including the stimulation of interferon production, together with the well-documented efficacy of certain probiotics in the therapy of rotavirus diarrhea suggests the potential for a role for these agents in PI-IBS. The efficacy of some probiotics in preferentially relieving 'gas-related' symptoms may be related to qualitative changes in the colonic flora, as described earlier, or through the suppression of Small intestinal bacterial overgrowth (SIBO) , as there are reports of efficacy of probiotics in SIBO.

The aim of the proposed study is to investigate whether the probiotic preparation "co biotic" can change the composition of fecal bile acids, fatty acids and bacterial composition, and whether such changes, if they occur, are correlated to a change in the symptoms of patients with IBS.

Materials and methods:

Patients diagnosed as having IBS by the Rome III criteria will be included in the study.

Study subjects will be interviewed by a physician who will asses the diagnosis of IBS according to the Rome III criteria. Subjects will sign an informed consent and fill an IBS questionnaire and a health related quality of life questionnaire,

A fecal sample will be obtained

The subject will receive the probiotic product in a dose of 2 tablets/day, or a placebo containing all the active ingredients in the probiotic capsule, besides the bacteria, for 4 weeks. They will then enter a washout period of 2 weeks in which they will not receive anything, and then another 4 weeks in which they will receive the probiotic product in a dose of 2 tablets/day, or a placebo. Patients will be randomized so that they will receive the study drug for 4 weeks and the placebo for 4 weeks, in a double-blinded fashion. Thus each patient will be his own control.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: co-biotic
Drug: placebo 2T/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Study of the Effect of Probiotics "Co-Biotic" (TM)on Symptoms and Fecal Bacterial Composition in IBS Patients

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • clinical improvement as judged by IBS questionnaire, change in fecal bacterial composition secondary: change the composition of fecal bile acids, fatty acids and bacterial composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • change the composition of fecal bile acids, fatty acids and bacterial composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: probiotics
patients with IBS that will receive investigational treatment for 4 weeks
Drug: co-biotic
give probiotic 2 t/day
Placebo Comparator: Placebo
cross over of patients from arm 1
Drug: placebo 2T/day
cross over of patients from study arm to placebo arm

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS by Rome III criteria

Exclusion Criteria:

  • other GI disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846170

Locations
Israel
Meir Medical center
Kefar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Professor Fred Konokoff, Meir Medical center
ClinicalTrials.gov Identifier: NCT00846170     History of Changes
Other Study ID Numbers: PB-01-09
Study First Received: February 16, 2009
Last Updated: May 16, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Irritable bowel syndrome probiotics

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

ClinicalTrials.gov processed this record on October 01, 2014