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NCT00934453 · ClinicalTrials.gov registry record · Phase 1
Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT00934453: Completed Phase 1 study of Healthy, sponsored by Massachusetts General Hospital.
NCT00934453 is a Phase 1 study of Healthy that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00934453, a Phase 1 study of Healthy, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10\^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be asked about any medical problems that have come up since the last study visit, have vital signs taken, review current medication use, and review any signs of potential adverse events. Blood and urine samples will also be collected at these visits, as well as throat and stool samples. Our goal is to assess the safety and tolerability of LGG when administered to healthy adult volunteers twice a day. Assessment of safety will be determined by vital sign measurements, physical examinations, clinical laboratory tests, and from the incidence and severity of adverse events that occur during study participation. Additionally, we will assess whether LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess the effect of LGG on the bacteria that normally live in the throat and GI tract by using culture-independent techniques. Volunteers enrolled in this study will also be invited to participate in a companion genetic study that will investigate the host immune response to the bacteria in LGG.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Lactobacillus rhamnosus GG ATCC 53103
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00934453
The ClinicalTrials.gov registry entry for NCT00934453 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00934453 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00934453 about?
NCT00934453 is a clinical study titled "Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Healthy Volunteers". This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10\^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's mi...
What is the current status of trial NCT00934453?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2009-12. Estimated completion is 2012-05.
What conditions does trial NCT00934453 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00934453?
The interventions under investigation include: Placebo (BIOLOGICAL), Lactobacillus rhamnosus GG ATCC 53103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00934453?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00934453 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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