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Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

Colic Clinical Trial

Official title:
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

Clinical Trial Summary

This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.

Clinical Trial Description

This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.

Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01849991
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact
Status Completed
Phase Phase 1
Start date September 2013
Completion date April 2016
View Details
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