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

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
GastrointestinalColic
Interventions
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.

Trial Locations (1)

77030

University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER

NCT01849991 - Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic | Biotech Hunter | Biotech Hunter