Phase
Condition
Colic
Treatment
N/AClinical Study ID
Ages < 9 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion Criteria:
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 tolactating 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 toenrolment 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
Study Design
Study Description
Connect with a study center
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Tlalpan 14080
MexicoActive - Recruiting
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