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

NCT ID: NCT00922727

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-07-31

Brief 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.

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.

Conditions

Colic; Gastrointestinal Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

L. reuteri

Intervention Type: BIOLOGICAL

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.

Sunflower Oil

Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia.

Group Type: PLACEBO_COMPARATOR

Sunflower Oil

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

BioGaia Drops; Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

J. Marc Rhoads

Director of Pediatric Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Marc Rhoads, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

Mangalat N, Liu Y, Fatheree NY, Ferris MJ, Van Arsdall MR, Chen Z, Rahbar MH, Gleason WA, Norori J, Tran DQ, Rhoads JM. Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.

Reference Type: RESULT

PMID: 22970150 (View on PubMed)

Other Identifiers

R21AT003519-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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U01AT003519

Identifier Type: NIH

Identifier Source: secondary_id

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HS-MSC-08-0266

Identifier Type: -

Identifier Source: org_study_id