Prevention of Colic With the Probiotic Lactobacillus Reuteri
Primary Purpose
Colic
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM 17938
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Colic focused on measuring colic, probiotic, Lactobacillus reuteri, prevention
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lactobacillus reuteri group
Placebo group
Arm Description
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Placebo (5 drops) for 28 days
Outcomes
Primary Outcome Measures
Event number of colic
Secondary Outcome Measures
Full Information
NCT ID
NCT02577133
First Posted
October 14, 2015
Last Updated
October 15, 2015
Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
1. Study Identification
Unique Protocol Identification Number
NCT02577133
Brief Title
Prevention of Colic With the Probiotic Lactobacillus Reuteri
Official Title
Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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-
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
Keywords
colic, probiotic, Lactobacillus reuteri, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
478 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus reuteri group
Arm Type
Active Comparator
Arm Description
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (5 drops) for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Other Intervention Name(s)
BioGaia
Intervention Description
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo consisted of an identical bottle with distilled water
Primary Outcome Measure Information:
Title
Event number of colic
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Héctor Javier Varona Bobadilla, Dr.
Phone
(52) 55 56 24 65 00
Ext
5423
Email
kavel_555@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Héctor Javier Varona Bobadilla, Dr.
Organizational Affiliation
Secretaria de Marina-Armada de México (Mexican Navy)
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Prevention of Colic With the Probiotic Lactobacillus Reuteri
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