Major Depressive DisorderPhase 4NCT01337609
Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder
A Phase 4 study testing Ganeden BC30 in people with Major Depressive Disorder and Irritable Bowel Syndrome, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Irritable Bowel Syndrome
- What is being tested?
- Ganeden BC30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Burlington Medical Associates
Burlington, Massachusetts, 01803
Charles River Medical Associates
Westborough, Massachusetts, 01581
About this study
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)
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.
- Being tested
- Ganeden BC30, Placebo (sugar pill), Ganeden BC30, Placebo (sugar pill)
- Keywords
- Depression, Irritable Bowel Syndrome, Probiotic, Bacillus Coagulans
- Medical subject headings
- Depressive Disorder, Major, Irritable Bowel Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganeden BC30Drug
2 billion CFU per capsule; One pill daily for 60 days
Placebo (sugar pill)Other
1 pill daily for 60 days
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
| Study group | Role | What they receive |
|---|---|---|
| GanedenBC30 | Experimental | Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days. Receives: Drug: Ganeden BC30 |
| Sugar pill | Placebo comparator | Arm 2 will take placebo (sugar pill) for 60 days. Receives: 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. Receives: Other: Ganeden BC30, Placebo (sugar pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
Secondary outcomes (4)
IBS Severity Scoring System (IBS-SSS)
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.
Measured: Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit
Visual Analog Scale (VAS)
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.
Measured: Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit
Adequate Relief of IBS Pain (AR-IBS)
The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.
Measured: Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit
Patient Global Impression of Change (PGI-C) - IBS Symptoms
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.
Measured: Administered at each of 8 visits (every 10 days), Endpoint is Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ganeden Biotech, Inc.
- Responsible party
- Principal investigator, Maurizio Fava, MD, Massachusetts General Hospital
- Investigators
- Maurizio Fava, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337609
- Sponsor's protocol ID
- 2008P002387
- Status last verified
- Aug 2013
- First submitted
- 15 Apr 2011
- Last updated
- 9 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01337609
- Acronym / sponsor ID
- 2008P002387
- Keywords
- Depression, Irritable Bowel Syndrome, Probiotic, Bacillus Coagulans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ganeden Biotech, Inc.
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Posted 9 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GanedenBC30 | Experimental | Drug: Ganeden BC30Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days. |
| Sugar pill | Placebo comparator | Other: Placebo (sugar pill)Arm 2 will take placebo (sugar pill) for 60 days. |
| Ganeden BC30, Sugar pill | Other | Other: Ganeden BC30, Placebo (sugar pill)Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganeden BC302 billion CFU per capsule; One pill daily for 60 days | Drug | GanedenBC30 |
| Placebo (sugar pill)1 pill daily for 60 days | Other | Sugar pill |
| 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 | Other | Ganeden BC30, Sugar pill |
Primary outcome
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.
4 secondary outcomes
IBS Severity Scoring System (IBS-SSS)
Time frame: 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
Adequate Relief of IBS Pain (AR-IBS)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Massachusetts General Hospital Depression Clinical and Research Program WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Fava, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganeden BC30 in people with Major Depressive Disorder and Irritable Bowel Syndrome, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.