Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 478
- Primary Endpoint
- Event number of colic
Study Overview
Brief 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.
Detailed Description
Methods:
This study is planned for October 2015 to October 2016 aiming newborns born population in Naval Hospital
Inclusion:
- Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation
- Appropriate weight for gestational age
- ≥than 8 Apgar at 5 minutes
- Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- No congenital or physical abnormalities on physical examination at birth.
- Availability during the study period.
- Thorough understanding of the protocol by parents
- Informed Consent is signed by both parents.
Exclusion:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 1 Week (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation.
- •Appropriate weight for gestational age
- •≥than 8 Apgar at 5 minutes
- •Egress at the first 24-48 hours of life of the newborn with the mother of hospital
- •No congenital or physical abnormalities on physical examination at birth.
- •Availability during the study period.
- •Thorough understanding of the protocol by parents
- •Informed Consent is signed by both parents.
Exclusion Criteria
- •Administration of antibiotics to the mother for a week before the birth of the newborn.
- •Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.
- •Medication Management newborn different routine prescribed at birth.
Outcomes
Primary Outcomes
Event number of colic
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Jorge Ivan Valencia Moncada
Prevention of colic with the probiotic Lactobacillus reuteri DSM 17938 in Mexican infants: randomized, double-blind study
Hospital General Naval de Alta Especialidad - Escuela Medico Naval