Safety of Lactobacillus Reuteri in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica PRISMA
Information provided by (Responsible Party):
Richard A. Oberhelman, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT00774163
First received: October 15, 2008
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.


Condition Intervention Phase
Healthy
Biological: Lactobacillus reuteri
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • Number of Participants With a Positive Blood Culture for L. Reuteri [ Time Frame: partipants were followed for an average of 36 days ] [ Designated as safety issue: Yes ]
    To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).

  • Mean Daily Temperature [ Time Frame: 5 days of study product administration ] [ Designated as safety issue: Yes ]
    Measured daily during 5 days of study product administration

  • Leukocyte Count on Day 5 [ Time Frame: Measured on day 5 ] [ Designated as safety issue: Yes ]
  • Serum Alanine Aminotransferase (ALT) in Female Participants [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
  • Serum ALT in Males [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
  • Serum Aspartate Aminotransferase (AST) in Females [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
  • Serum AST in Males [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
  • Blood Urea Nitrogen [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
  • Serum Creatinine [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Subjects With at Least One PCR Positive Stool Specimen [ Time Frame: Average of 36 day follow up period ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]
  • Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported [ Time Frame: Day 0 through 6 weeks after Day 0 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
Biological: Lactobacillus reuteri
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
Other Name: BioGaia Probiotic Drops
Placebo Comparator: 2
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
Other: Placebo
5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Detailed Description:

This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:

A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 18-65 with no exclusion criteria
  • Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).

Exclusion Criteria:

  • No enrollment of family members in households where any of the following are present:

    • Another study participant in the household
    • Pregnancy or current breastfeeding by any household member
    • Presence of an infant under age 6 months living in the household
    • Presence of immune suppressed individuals or use of immunosuppressive agents (corticosteroids, methotrexate) by any household member
    • Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
  • Allergy to penicillin or cephalosporins
  • History of antibiotic use in the last 30 days
  • Use of probiotic products within the past 90 days
  • History of diarrheal illness within the past 30 days
  • Presence of fever or a pre-existing adverse event monitored in the study
  • Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774163

Locations
Peru
Community of Santa Clara
Iquitos, Loreto, Peru
Sponsors and Collaborators
Tulane University School of Medicine
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica PRISMA
Investigators
Principal Investigator: Richard A Oberhelman, MD Tulane School of Public Health and Tropical Medicine
Study Director: Margaret N Kosek, MD Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Richard A. Oberhelman, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT00774163     History of Changes
Other Study ID Numbers: FDA IND# 13710, 1R01AT002733-01A1
Study First Received: October 15, 2008
Results First Received: June 13, 2012
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University School of Medicine:
probiotics
lactobacillus
reuteri
none (safety only)

ClinicalTrials.gov processed this record on April 22, 2014