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

This study has been terminated.
(Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early.)
Sponsor:
Collaborator:
Ganeden Biotech, Inc.
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01337609
First received: April 15, 2011
Last updated: August 7, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: May 29, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Depression
Irritable Bowel Syndrome
Probiotic
Bacillus Coagulans

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Irritable Bowel Syndrome
Syndrome
Behavioral Symptoms
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Mental Disorders
Mood Disorders
Pathologic Processes
Contraceptives, Oral
Contraceptive Agents
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014