Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months

Overview

Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.

The study is a single center Phase 1 double blind placebo controlled trial of Lactobacillus reuteri DSM 17938 in children aged 2-24 months. The study population is based in a community with a registered clinical trial center in rural Peru where this protocol can be done in a highly controlled setting. The study is intended to enroll healthy children living in a resource constrained setting where chronic undernutrition and diarrheal disease is common, as this is the population that is most likely to receive benefit from the use of this and or other probiotic products for the treatment of acute infectious diarrhea and environmental enteropathy. Up to 100 subjects will be enrolled in order to obtain the randomization of 60 subjects, who will receive study product or placebo at a ratio of 2:1. Participants will be enrolled between the ages of 8 weeks and 24 months. There will be no age stratification. Participants will be screened with a baseline history and physical examination and laboratory tests to determine the HIV status of the child, as well baseline laboratory tests to evaluate occult infections, hepatic function, and renal function. Upon randomization subjects will be screened and randomized to a treatment arm. Product will be administered under the direct supervision of study staff daily for 5 days. The primary outcome is the safety and tolerability of the product at this dose and formulation. Safety will be assessed by the monitoring of baseline laboratory tests at 5 and 28 days following the initiation of therapy and by AE monitoring. Tolerability will be evaluated by analyzing 28 day diary cards that are distributed to all randomized subjects on which parents record their child's symptoms (specifically fever, anorexia/oral intake, vomiting, diarrhea, irritability, rash, wheezing, or open fields which allows them to describe any issue their child may experience and grade its severity) . Secondary outcomes include: 1\) The assessment of the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. This will be determined by and endpoint PCR assay for L. reuteri done on stool collected on D3, D5, D12, D15, D18, D24, D28, D36 on all participants. The planned enrollment period is four months and the participation of individual subjects is for 3 months. The study should be completed in 7 months. Safety monitoring by treatment group, i.e., infants assigned to active or placebo study product will be conducted by NIDDK appointed DSMB under the direction of the NIDDK Program Official.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes