Colic Clinical Trial
Official title:
Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
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.
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:
- 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.
Elimination
- Loss of monitoring
- Abandonment by parents
- Diagnosis of allergy to cow's milk protein (confirmed by resolution of symptoms after
switching to Formula hypo allergenic or free feeding cow's milk by the mother in
breastfed children).
- Diagnosis of structural alterations or gastrointestinal illness to explain the symptoms
of colic in the following months after the inclusion
Interventions:
The patients enrolled will receive probiotics (1000000000 CFU per day) or placebo every days
for 28 days
Weekly, each patient will be called twice to interrogate the number of events colic as well
as the different variables under study
After birth, on 15, 30, 45 and 60 of life will be cited for clinical examination and review
and weight dropper bottle of probiotic
• Principal: Number of events or inconsolable crying
• Secondary: Average or evacuations / day Average or regurgitation / day Drugs to decrease
excessive crying Medical reviews for excessive crying Changes feeding for excessive crying
Level of satisfaction with the care of the newborn (numerical scale from 0: the worst
possible, 10: completely satisfied)
• Universal variables
Weight:
Size:
Gender Weeks gestation Type of birth Feeding of formula / breast-
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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