A Prospective, Single-arm, Open labeled, multi-centric, observational, real-world evidence gathering study to evaluate benefits of supplementation of Lactobacillus reuteri DSM 17938 in full term infants with infantile colic

Global Generics India Dr Reddys Laboratories Limited0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•1.Age: from birth to 5 months of age
•2.Diagnosed with infantile colic using Rome IV Criteria (Infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week) and recommended with nutritional supplementation of Lactobacillus reuteri for infantile colic by the treating physician
•3.Full term infant, i.e. gestational age between 37 and 42 weeks
•4.Breast fed, either exclusively or predominantly, i.e. more than 50% time
•5.Birth weight >2500g
•6.Apgar score >= 8 at 5 minutes at birth
•7.Written informed consent from parents to share data as per protocol and adhere to routine follow up visits as required by treating physician
•8.Parent(s) willing to maintain same infant feeding mode throughout study period
•9.Parent(s) willingness and ability to fill in diary and questionnaires

•1.Significant co-existing illness or major medical problem, which in opinion of treating physician does not make patient suitable for participation in study
•2.Any other gastrointestinal disorder
•3.Failure to thrive
•4.Use of antibiotics two weeks before enrolment and throughout the intervention period, for both infant and mother
•5.Use of probiotics two weeks before enrolment and throughout the intervention period, for both infant (infant formula and/or supplementation) and mother
•6.Use of acid suppressive therapy two weeks before enrolment and throughout the intervention period.
•7.Infant receiving solid foods, such as cereals, mashed fruits or vegetable puree
•8.Participation in any other interventional study

Sponsor

Global Generics India Dr Reddys Laboratories Limited