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NCT01337609 · ClinicalTrials.gov registry record · Phase 4
Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT01337609: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01337609 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337609, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Ganeden BC30
- OTHER Placebo (sugar pill)
- OTHER Ganeden BC30, Placebo (sugar pill)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
Why NCT01337609 stopped before completion
NCT01337609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Ganeden BC30 is the first listed.
NCT01337609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337609 about?
NCT01337609 is a clinical study titled "Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder". 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 th...
What is the current status of trial NCT01337609?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2011-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01337609?
The interventions under investigation include: Ganeden BC30 (DRUG), Placebo (sugar pill) (OTHER), Ganeden BC30, Placebo (sugar pill) (OTHER).
Who is sponsoring clinical trial NCT01337609?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337609's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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