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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 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.

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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.

Conditions Studied

Healthy Influenza

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

FieldValue
Enrollment Target 30 participants
Start Date 2012-02
Est. Completion 2013-05
Phase Phase 1

Sponsor

Patricia L. Hibberd

1 total trials

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What the Registry Record Tells You About NCT01545349

The ClinicalTrials.gov registry entry for NCT01545349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 (95% lower). The listed sponsor is Patricia L. Hibberd, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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, or report a data error.