Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder - Full Text View

Purpose

The purpose of this study is to determine the safety and effectiveness of a nutritional supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which when taken in large enough amounts are supposed to provide a health benefit. The investigators would like to see whether this supplement can be used as a treatment for Irritable Bowel Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the study will have both IBS and MDD. In order to find out if GanedenBC30 is effective in treating IBS and MDD, the investigators will compare it to a placebo. About 32 people will take part in this research study. About half of these 32 people will take part at Charles River Medical Associates and half will take part at Burlington Medical Associates. Participants will be recruited from among patients already being seen at Charles River Medical Associates or Burlington Medical Associates for their primary care. The study will last for two months, during which time participants will make eight study visits and will take either Ganeden BC30 or placebo. The investigators hypothesize that subjects treated with the probiotic will have significantly better outcomes with regard to depression and IBS symptoms compared to those who receive placebo.

Condition	Intervention	Phase
Major Depressive Disorder Irritable Bowel Syndrome	Drug: Ganeden BC30 Other: Placebo (sugar pill) Other: Ganeden BC30, Placebo (sugar pill)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Placebo-Controlled Study of the Probiotic Ganeden BC30 (Bacillus Coagulans GBI-30, 6068) in Irritable Bowel Syndrome Comorbid With Major Depressive Disorder (MDD)

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit ] [ Designated as safety issue: No ]
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.

Secondary Outcome Measures:

IBS Severity Scoring System (IBS-SSS) [ Time Frame: Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit ] [ Designated as safety issue: No ]
The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.
Visual Analog Scale (VAS) [ Time Frame: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit ] [ Designated as safety issue: No ]
The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.
Adequate Relief of IBS Pain (AR-IBS) [ Time Frame: Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit ] [ Designated as safety issue: No ]
The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.
Patient Global Impression of Change (PGI-C) - IBS Symptoms [ Time Frame: Administered at each of 8 visits (every 10 days), Endpoint is Final Visit ] [ Designated as safety issue: No ]
The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.

Enrollment:	5
Study Start Date:	June 2011
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GanedenBC30 Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.	Drug: Ganeden BC30 2 billion CFU per capsule; One pill daily for 60 days
Placebo Comparator: Sugar pill Arm 2 will take placebo (sugar pill) for 60 days.	Other: Placebo (sugar pill) 1 pill daily for 60 days
Ganeden BC30, Sugar pill Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.	Other: Ganeden BC30, Placebo (sugar pill) Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Able to give Informed Consent
Meet criteria for Irritable Bowel Syndrome
Meet criteria for Major Depressive Disorder
Men and women ages 18 to 65
Women of childbearing potential must be using an adequate methods of contraception
Can be on an antidepressant medications, but must have been on the medication for at least 8 weeks and at a stable dose for 4 weeks
Can be on medications for IBS, but must have been on medications for at least 8 weeks and at a stable dose for 4 weeks

Exclusion Criteria:

Patients who have failed one or more trials of probiotics for IBS
Patients who report an inadequate response to less than two or more than four adequate trails of antidepressant treatments during the current depressive episode at a therapeutic dose for an adequate duration
Women who are pregnant or breastfeeding
Patients with "alarm signs" or "red flags" as defined by American Gastroenterological Association (AGA) are excluded [6], unless they have been fully evaluated to rule out other significant diseases.
Patients with known diagnoses of digestive organic disease, celiac disease and lactose intolerance prior to the screening.
Patients who report an inadequate response (less than 50% decrease in depressive symptom severity) to less than two or more than four prior adequate trials of antidepressant treatments during the current depressive episode (including monotherapy treatment and distinct combination regimens) at a therapeutic dose (as defined by the MGH-ATRQ) and for an adequate duration (minimum six weeks for any monotherapy).
Patients who report treatment with adjunctive medications to their antidepressant for a minimum of four weeks during the current depressive episode.
Patients with a current need for involuntary commitment or who have been hospitalized within four weeks of the Screening Visit for the current major depressive episode.
Patients who have received ECT during the current episode.
Patients who have a current Axis I diagnosis of:

Delirium, dementia, amnestic, or other cognitive disorder; Schizophrenia or other psychotic disorder, based on the PDSQ; Bipolar I or II disorder, based on the PDSQ; Patients with a clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.
Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months, based on the PDSQ.
Patients receiving new onset depression-focused psychotherapy within 6 weeks of screening, or at any time during participation in the trial.
Patients who have been previously randomized in a probiotics clinical trial (lifetime).
Patients who have participated in any clinical trial with an investigational drug or device within the past month.
Patients who, in the opinion of the investigator, are actively suicidal or homicidal and at significant risk for suicide or homicide.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337609

Locations

United States, Massachusetts
Burlington Medical Associates
Burlington, Massachusetts, United States, 01803
Charles River Medical Associates
Westborough, Massachusetts, United States, 01581

Sponsors and Collaborators

Massachusetts General Hospital

Ganeden Biotech, Inc.

Investigators

Principal Investigator:

Maurizio Fava, MD

Massachusetts General Hospital

More Information

Additional Information:

Massachusetts General Hospital Depression Clinical and Research Program Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Maurizio Fava, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01337609 History of Changes
Other Study ID Numbers:	2008P002387
Study First Received:	April 15, 2011
Last Updated:	November 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Depression
Irritable Bowel Syndrome
Probiotic
Bacillus Coagulans

Additional relevant MeSH terms:

Depressive Disorder
Depression
Irritable Bowel Syndrome
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013