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Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults

NCT00922727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-25

No results posted yet for this study

Summary

This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.

Conditions

  • Colic
  • Gastrointestinal Tract Infections

Interventions

BIOLOGICAL

L. reuteri

The oil drops contains 10\^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10\^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10\^8 CFU/ 5 drops and less than 8 x 10\^8 CFU/ 5 drops.

BIOLOGICAL

Sunflower Oil

As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10\^8 CFU/ 5 drops.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • J. Marc Rhoads, M.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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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 NCT00922727 on ClinicalTrials.gov