Status:
COMPLETED
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Gastrointestinal
Colic
Eligibility:
All Genders
3-3 years
Phase:
PHASE1
Brief 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) ...
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 ...
Eligibility Criteria
Inclusion
- Full-term babies with colic (21-90 days old, who cry/fuss \> 3h daily x \> 3d wk)
- baby must have more than 3h crying for enrollment
Exclusion
- severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis)
- failure to thrive
- intrauterine growth retardation
- hematochezia (blood in the stools)
- diarrhea (watery stools that takes the shape of a container \> 5x daily)
- fever (38.2 degrees)
- Premature infants (\<37 wk gestation)
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01849991
Start Date
September 1 2013
End Date
April 1 2016
Last Update
January 30 2018
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030