- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01337609
Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder
August 7, 2013 updated by: Maurizio Fava, MD, Massachusetts General Hospital
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)
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Burlington, Massachusetts, United States, 01803
- Burlington Medical Associates
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Westborough, Massachusetts, United States, 01581
- Charles River Medical Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GanedenBC30
Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
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2 billion CFU per capsule; One pill daily for 60 days
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Placebo Comparator: Sugar pill
Arm 2 will take placebo (sugar pill) for 60 days.
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1 pill daily for 60 days
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Other: Ganeden BC30, Sugar pill
Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
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Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBS Severity Scoring System (IBS-SSS)
Time Frame: Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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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.
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Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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Visual Analog Scale (VAS)
Time Frame: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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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.
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Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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Adequate Relief of IBS Pain (AR-IBS)
Time Frame: Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit
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The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.
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Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit
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Patient Global Impression of Change (PGI-C) - IBS Symptoms
Time Frame: Administered at each of 8 visits (every 10 days), Endpoint is Final Visit
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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.
|
Administered at each of 8 visits (every 10 days), Endpoint is Final Visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
April 18, 2011
First Posted (Estimate)
April 19, 2011
Study Record Updates
Last Update Posted (Estimate)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008P002387
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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