Clinical Trial of L. Reuteri in Infantile Colic 2017 (Colic2017)
Infantile Colic
About this trial
This is an interventional treatment trial for Infantile Colic
Eligibility Criteria
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 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 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
Sites / Locations
- Hospital General Dr. Manuel Gea GonzalezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
HMilkProb
HMilkPlacebo
IFormProb
IFormPlacebo
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
The placebo consists of an identical formulation except that the L. reuteri is not present
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
The placebo consists of an identical formulation except that the L. reuteri is not present