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Status:

UNKNOWN

Clinical Trial of L. Reuteri in Infantile Colic 2017

Lead Sponsor:

Innovacion y Desarrollo de Estrategias en Salud

Collaborating Sponsors:

BioGaia AB

Conditions:

Infantile Colic

Eligibility:

All Genders

1-9 years

Phase:

NA

Brief Summary

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed w...

Detailed Description

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months...

Eligibility Criteria

Inclusion

  • Younger than 10 weeks of age
  • Full term infant (37-42 weeks gestational age)
  • Birth weight ≥ 2,500g
  • Apgar score ≥ 7 at 5 minutes
  • Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
  • Parental motivation to postpone changes in the infant feeding mode, unless necessary
  • Stated availability throughout the study period
  • Parent(s) willingness and ability to fill out charts and questionnaires
  • Signed informed consent

Exclusion

  • Failure to thrive
  • Chronic illness or major medical problem
  • Gastrointestinal disease
  • Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
  • Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
  • Use of proton pump inhibitors in the week (7 days) prior to enrolment
  • If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period
  • Use of infant formula with hydrolysed protein
  • Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
  • Change of feeding mode planned by parents during the study period

Key Trial Info

Start Date :

January 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 30 2020

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT03360253

Start Date

January 1 2018

End Date

January 30 2020

Last Update

July 30 2019

Active Locations (1)

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1

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Tlalpan, Mexico, 14080