Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01337609
The ClinicalTrials.gov registry entry for NCT01337609 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ganeden BC30 is the first listed.
NCT01337609 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.