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Prevention of Colic With the Probiotic Lactobacillus Reuteri

NCT02577133 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2015-10-16

No results posted yet for this study

Summary

Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs.

There is now enough evidence for the treatment of colic using probiotics, especially Lactobacillus reuteri.

The investigators study aims to demonstrate the utility for the prevention of colic with L. reuteri and thereby avoid the problems caused by this pathology.

Objective: Compare the number of events of colic among infants with oral probiotic Lactobacillus reuteri during the first month of life versus infants with placebo

Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. The investigators trial will be performed at Naval Hospital in Mexico City.

Conditions

  • Colic

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938

Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days

DIETARY_SUPPLEMENT

Placebo

The placebo consisted of an identical bottle with distilled water

Sponsors & Collaborators

  • Hospital General Naval de Alta Especialidad - Escuela Medico Naval

    lead OTHER_GOV

Principal Investigators

  • Héctor Javier Varona Bobadilla, Dr. · Secretaria de Marina-Armada de México (Mexican Navy)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-01-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577133 on ClinicalTrials.gov