Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder

NCT01337609 | Terminated Phase 4 Results

• 1 other identifier: 2008P002387
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Major Depressive Disorder; Irritable Bowel Syndrome

Keywords

Depression; Irritable Bowel Syndrome; Probiotic; Bacillus Coagulans

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

  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.

  Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit

Secondary Outcomes (4)

• IBS Severity Scoring System (IBS-SSS)

  Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit

• Visual Analog Scale (VAS)

  Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit

• Adequate Relief of IBS Pain (AR-IBS)

  Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit

• Patient Global Impression of Change (PGI-C) - IBS Symptoms

  Administered at each of 8 visits (every 10 days), Endpoint is Final Visit

Study Arms (3)

GanedenBC30

EXPERIMENTAL

Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.

Drug: Ganeden BC30

Sugar pill

PLACEBO COMPARATOR

Arm 2 will take placebo (sugar pill) for 60 days.

Other: Placebo (sugar pill)

Ganeden BC30, Sugar pill

OTHER

Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.

Other: Ganeden BC30, Placebo (sugar pill)

Interventions

Ganeden BC30 DRUG

2 billion CFU per capsule; One pill daily for 60 days

GanedenBC30

Placebo (sugar pill) OTHER

1 pill daily for 60 days

Sugar pill

Ganeden BC30, Placebo (sugar pill) OTHER

Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days

Ganeden BC30, Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ganeden Biotech, Inc.: collaborator

Study Sites (2)

Burlington Medical Associates

Burlington, Massachusetts, 01803, United States

Location

Charles River Medical Associates

Westborough, Massachusetts, 01581, United States

Location

Related Links

• Massachusetts General Hospital Depression Clinical and Research Program Website

MeSH Terms

Conditions

Depressive Disorder, Major; Irritable Bowel Syndrome; Depression

Interventions

Sugars

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and data were not analyzed.

Results Point of Contact

• Title: Dr. Maurizio Fava
• Organization: Massachusetts General Hospital

mfava@partners.org

617-724-2513

Study Officials

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 9, 2013
• Results First Posted: August 9, 2013

Record last verified: 2013-08

Locations

US (2)