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Safety of Lactobacillus Reuteri in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00774163
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : July 12, 2013
Last Update Posted : December 19, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins Bloomberg School of Public Health
Asociación Benéfica Prisma
Information provided by (Responsible Party):
Richard A. Oberhelman, Tulane University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 15, 2008
First Posted Date  ICMJE October 17, 2008
Results First Submitted Date  ICMJE June 13, 2012
Results First Posted Date  ICMJE July 12, 2013
Last Update Posted Date December 19, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • Number of Participants With a Positive Blood Culture for L. Reuteri [ Time Frame: participants were followed for an average of 36 days ]
    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 ]
    Measured daily during 5 days of study product administration
  • Leukocyte Count on Day 5 [ Time Frame: Measured on day 5 ]
  • Serum Alanine Aminotransferase (ALT) in Female Participants [ Time Frame: Day 5 ]
  • Serum ALT in Males [ Time Frame: Day 5 ]
  • Serum Aspartate Aminotransferase (AST) in Females [ Time Frame: Day 5 ]
  • Serum AST in Males [ Time Frame: Day 5 ]
  • Blood Urea Nitrogen [ Time Frame: Day 5 ]
  • Serum Creatinine [ Time Frame: Day 5 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
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 ]
Change History Complete list of historical versions of study NCT00774163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • Number of Subjects With at Least One PCR Positive Stool Specimen [ Time Frame: Average of 36 day follow up period ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
  • To evaluate the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. [ Time Frame: end of study ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Lactobacillus Reuteri in Healthy Volunteers
Official Title  ICMJE Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers
Brief Summary 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2009)
45
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2008)
22
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00774163
Other Study ID Numbers  ICMJE FDA IND# 13710
1R01AT002733-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard A. Oberhelman, Tulane University School of Medicine
Study Sponsor  ICMJE Tulane University School of Medicine
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Johns Hopkins Bloomberg School of Public Health
  • Asociación Benéfica Prisma
Investigators  ICMJE
Principal Investigator: Richard A Oberhelman, MD Tulane School of Public Health and Tropical Medicine
Study Director: Margaret N Kosek, MD Johns Hopkins Bloomberg School of Public Health
PRS Account Tulane University
Verification Date December 2016

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