PROBIOTICS TRIAL

A Double-Blind, Placebo-Controlled Study of the PROBIOTIC GANEDENBC30 (Baccillus Coagulans GBI-30,6086) in Irritable Bowel Syndrome Comorbid with Major Depressive Disorder.

Study Phase

Purpose

Is to assess the efficacy and safety of probiotics bacteria GanedenBC30 (Bacillus coagulens GBI-30,6086) in outpatients with Irritable Bowel Syndrome and Major Depressive Disorder.

The study population will include those who meet the following inclusion/exclusion criteria, some of which are:

Inclusion criteria

1. Signed & dated, informed consent prior to the initiation of any study procedures.
   
2. Patient needs to meet the ROME III Diagnostic Criteria for IBS at study entry.
   
3. Men & Women, ages 18 to 65.
4. A normal sigmoidoscopy of barium enema and/or normal colonoscopy within 5 years is required.
5. Patients are allowed to be on medications for IBS including antisposmodics, antidiarrheals, bulking agents/fiber, and serotonergic agents (including serotonergic antidepressants) they must have been on those treatments for at least 8 weeks and on the same dose for at least 4 weeks prior to baseline and with a baseline (VAS) pain, bloating and discomfort score between 3 and 7 at study entry.
6. Patient with a diagnosis of major depressive episode as defined by the self-rated DSQ.
7. Patient must be able to reliably rated on the psychiatric scale required by the protocol.

Exclusion criteria

1. WOCBP who are unwilling or unable to use an acceptable method of contraception for the entire study and for up to 4 weeks after the last dose of study drug.
   
2. WOCBP with a positive pregnancy test on enrollment or to study drug administration.
   
3. Patient has failed 1 or more trials of probiotics for IBS.

To inquire if you are eligible for this study or to hear more about it, please contact:

Lori Brazee
Clinical Research Coordinator
Office#: 781-505-8710
Email: lbrazee@pchi.partners.org