Probiotics in Irritable Bowel Syndrome

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: co-biotic; Drug: placebo 2T/day

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Kefar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IBS by Rome III criteria

Exclusion Criteria:

• other GI disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
change the composition of fecal bile acids, fatty acids and bacterial composition	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical improvement	2 years

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: February 16, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 8, 2015
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Irritable bowel syndrome probiotics
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PB-01-09