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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00922727
First received: June 15, 2009
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Colic
Gastrointestinal Tract Infections
 Biological: L. reuteri
Biological: Sunflower Oil
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated. [ Time Frame: 8/1/2009 - 7/1/2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922727

Locations
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: J. Marc Rhoads, M.D. The University of Texas Health Science Center, Houston
  More Information

Publications:

Responsible Party: J. Marc Rhoads, Director of Pediatric Gastroenterology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00922727     History of Changes
Other Study ID Numbers: HS-MSC-08-0266, R21AT003519-01A2, U01AT003519
Study First Received: June 15, 2009
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
L. reuteri
Cytokines
Toll like receptors
Healthy Adults
Probiotics

ClinicalTrials.gov processed this record on June 18, 2013