Probiotics in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Double Blind Placebo Controlled Study of the Effect of Probiotics "Co-Biotic" (TM)on Symptoms and Fecal Bacterial Composition in IBS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00846170
• Other study ID #: PB-01-09
• Status: Withdrawn
• Phase: Phase 3
• First received: February 16, 2009
• Last updated: March 8, 2015
• Start date: September 2010

Study information

• Verified date: May 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• IBS by Rome III criteria

Exclusion Criteria:

• other GI disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• co-biotic
give probiotic 2 t/day
• placebo 2T/day
cross over of patients from study arm to placebo arm

Locations

Country	Name	City	State
Israel	Meir Medical center	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	No
Primary	change the composition of fecal bile acids, fatty acids and bacterial composition		1 year	No
Secondary	clinical improvement		2 years	No