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

Completed · Phase 1 · Has a placebo group

Conditions studied: Gastrointestinal, Colic

In brief

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.

Key facts

Study ID

NCT01849991

Run by

The University of Texas Health Science Center, Houston

People needed

21

Starts

2013-09-01

Expected to finish

2016-04-01

Last updated by the study team

2018-01-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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