NCT01849991

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 3 Weeks – 3 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gastrointestinal
• Colic

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus reuteri	Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.
BIOLOGICAL	Placebo	Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-05-09
• Last updated: 2018-01-30

Locations

1 site across 1 country: United States