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

Phase 1

Completed

• Conditions: Colic; Gastrointestinal
• Interventions: Biological: Placebo; Biological: Lactobacillus reuteri

• Registration Number: NCT01849991
• Lead Sponsor: The University of Texas Health Science Center, Houston

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) 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.

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-09
• Study Start: 2013-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunflower Oil	Placebo	The second arm includes 15 subjects on placebo (sunflower oil.)
Lactobacillus reuteri	Lactobacillus reuteri	The first arm of the cohort will include 30 patients on LR (5x10\^8 cfu's orally once daily.)

Primary Outcome Measures

Name	Time	Method
45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.	92 days	1. Physical Examination of infants will be performed to evaluate any adverse effects of LR.; 2. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.

Secondary Outcome Measures

Name	Time	Method
Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.	1, 42 & 92 days	To examine for evidence of anti-inflammatory effects in the normal intestine, we will test fecal samples from all infants for calprotectin level.

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States