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Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine

NCT01545349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-11

No results posted yet for this 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

Interventions

BIOLOGICAL

Lactobacillus rhamnosus GG ATCC 53103 (LGG)

Study drug capsules (1x10\^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days

BIOLOGICAL

Placebo

Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.

BIOLOGICAL

Live attenuated influenza vaccine

0.2 mL pre-filled, single use intranasal spray

Sponsors & Collaborators

  • Patricia L. Hibberd

    lead OTHER

Principal Investigators

  • Patricia L Hibberd, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545349 on ClinicalTrials.gov