Prevention of Colic With the Probiotic Lactobacillus Reuteri

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colic

Treatments: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02577133

HGNAE-04

Details and patient eligibility

About

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.

Full 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:

• 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-

Enrollment: 478 estimated patients

Sex: All

Ages: 1 day to 1 week old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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478 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo group

Placebo Comparator group

Description:

Placebo (5 drops) for 28 days

Treatment:

Dietary Supplement: Placebo