Prevention of Colic With the Probiotic Lactobacillus Reuteri

October 15, 2015 updated by: Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  • 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-

Study Type

Interventional

Enrollment (Anticipated)

478

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lactobacillus reuteri group
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Dietary supplement: Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Other Names:
  • BioGaia
Placebo Comparator: Placebo group
Placebo (5 drops) for 28 days
Dietary supplement: Placebo
The placebo consisted of an identical bottle with distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event number of colic
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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