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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
Community of Santa Clara
Iquitos, Loreto, Peru
Number of Participants With a Positive Blood Culture for L. Reuteri
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: participants were followed for an average of 36 days
Mean Daily Temperature
Measured daily during 5 days of study product administration
Time frame: 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
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
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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