Clinical Trial of L. Reuteri in Infantile Colic 2017 (Colic2017)

Innovation and Development of Health Strategies

Status

Unknown

Conditions

Infantile Colic

Treatments

Dietary Supplement: L. reuteri DSM 17938 in drops

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03360253

Colic2017

Details and patient eligibility

About

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 with human milk (30% sample) or infant formula (70%)

Full 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 of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21

Enrollment

244 estimated patients

Sex

All

Ages

1 to 9 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

244 participants in 4 patient groups, including a placebo group

HMilkProb

Experimental group

Description:

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

Treatment:

Dietary Supplement: L. reuteri DSM 17938 in drops

HMilkPlacebo

Placebo Comparator group

Description:

The placebo consists of an identical formulation except that the L. reuteri is not present

Treatment:

Other: Placebo

IFormProb

Experimental group

Description:

Treatment: