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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit
Visual Analog Scale (VAS)
Time Frame: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
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.
Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
Adequate Relief of IBS Pain (AR-IBS)
Time Frame: Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit
The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.
Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit
Patient Global Impression of Change (PGI-C) - IBS Symptoms
Time Frame: Administered at each of 8 visits (every 10 days), Endpoint is Final Visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ganeden Biotech, Inc.

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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