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Safety of Lactobacillus Reuteri in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Tulane University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica PRISMA
Information provided by:
Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT00774163
First received: October 15, 2008
Last updated: July 22, 2010
Last verified: July 2010
History of Changes

October 15, 2008
July 22, 2010
February 2010
June 2010   (final data collection date for primary outcome measure)
To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture). [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00774163 on ClinicalTrials.gov Archive Site
  • To evaluate the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To assess the clinical tolerance of Lactobacillus reuteri (Lr) strain DSM 17938 following administration, based on presence of physical symptoms and adverse events. [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety of Lactobacillus Reuteri in Healthy Volunteers
Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

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.

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).
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
  • Other: Placebo
    5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
  • Experimental: 1
    Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
    Intervention: Biological: Lactobacillus reuteri
  • 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
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
October 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00774163
FDA IND# 13710, 1R01AT002733-01A1
No
Richard A. Oberhelman, MD, Tulane Unversity School of Public Health and Tropical Medicine
Tulane University School of Medicine
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Johns Hopkins Bloomberg School of Public Health
  • Asociacion Benefica PRISMA
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
Tulane University School of Medicine
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP