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

January 23, 2018 updated by: J. Marc Rhoads, The University of Texas Health Science Center, Houston

Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Adults (18 - 60 years old)
  • No other recognized illness

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Patient taking immunosuppressive medications, including oral corticosteroids
  • Positive result of HIV, Hepatitis B, and/or Hepatitis C test
  • Abnormal lab test results
  • Gastrointestinal related diseases and surgeries
  • Patients with an allergy to antibiotics
  • Presence of fever or a pre-existing adverse event monitored in the study
  • No more than two study participants in one household
  • Use of probiotics in the last 90 days
  • Diarrheal illness within the past 30 days
  • Recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks)
  • Current use of oral laxatives
  • Chronic alcohol use or more than 1 drink per day
  • Subjects with implanted prosthetic devices including prosthetic heart valves
  • Known sensitivity to sunflower oil or products containing linolenic/oleic acids
  • Will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the 6-month period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L. reuteri
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938.
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.
Other Names:
  • BioGaia Drops
Placebo Comparator: Sunflower Oil
Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia.
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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.
Time Frame: 8/1/2009 - 7/1/2009
8/1/2009 - 7/1/2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells.
Time Frame: 4/1/2009-7/1/2009
4/1/2009-7/1/2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-MSC-08-0266
  • R21AT003519-01A2 (U.S. NIH Grant/Contract)
  • U01AT003519 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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