A Phase 2/3 interventional study of Lactobacillus reuteri DSM 17938 and Placebo in Colic, sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval. Status unknown. Open to participants aged 1 Day to 1 Week. Per ClinicalTrials.gov, last updated 2015-10-16.
Sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Phase 2/3, Interventional, and Prevention
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:
Exclusion:
Elimination
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
Weight:
Size:
Gender Weeks gestation Type of birth Feeding of formula / breast-
153 studies on the registry are indexed under Colic; 19 are open to participants now.
This study's planned enrollment of 478 is above the median of 80 across 127 interventional studies indexed under Colic.
Browse Colic studies →Hospital General Naval de Alta Especialidad - Escuela Medico Naval is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Dietary Supplement: Lactobacillus reuteri DSM 17938
Placebo (5 drops) for 28 days
Dietary Supplement: Placebo
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
Also known as: BioGaia
The placebo consisted of an identical bottle with distilled water
Event number of colic
Time frame: 3 months
No study locations are listed for this record.
The record gives a start of Oct 2015, a primary completion of Jan 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Limosilactobacillus reuteri DSM-17938
Hospital General Naval de Alta Especialidad - Escuela Medico Naval