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NCT01545349 · ClinicalTrials.gov registry record · Phase 1
Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine
A Phase 1 study of Healthy and Influenza, sponsored by Patricia L. Hibberd.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01545349: Completed Phase 1 study of Healthy and Influenza, sponsored by Patricia L. Hibberd.
NCT01545349 is a Phase 1 study of Healthy and Influenza that has completed, run by Patricia L. Hibberd. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01545349, a Phase 1 study of Healthy and Influenza, has completed, sponsored by Patricia L. Hibberd.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are: 1. LGG or placebo administered twice daily will be safe and well tolerated in elderly subjects who have just received the live attenuated influenza vaccine, 2. The immune response to the influenza vaccine at day 21, 28, and 56 will be higher in the LGG group than the placebo group, 3. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, and 56 will be greater in the LGG group than the placebo group.
Primary Outcome
Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires. Additionally, subjects are encouraged to call the PI or study staff at any time if they are experiencing an adverse event.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Lactobacillus rhamnosus GG ATCC 53103 (LGG)
- BIOLOGICAL Live attenuated influenza vaccine
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01545349 record still lists
NCT01545349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01545349 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01545349 about?
NCT01545349 is a clinical study titled "Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine". This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that...
What is the current status of trial NCT01545349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-02. Estimated completion is 2013-05.
What conditions does trial NCT01545349 study?
This clinical trial studies the following conditions: Healthy, Influenza.
What interventions are being tested in trial NCT01545349?
The interventions under investigation include: Placebo (BIOLOGICAL), Lactobacillus rhamnosus GG ATCC 53103 (LGG) (BIOLOGICAL), Live attenuated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01545349?
This trial is sponsored by Patricia L. Hibberd, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01545349 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01545349's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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