Clinical trial NCT03360253: Clinical Trial of L. Reuteri in Infantile Colic 2017
Official title: Safety and Efficacy of Lactobacillus Reuteri DSM 17938 to Reduce the Crying Time in Infants With Colic: Randomised Controlled Trial With Two Parallel Arms. Version 3.3. Nov,11th,2016
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infantile Colic
Lead sponsor: Innovacion y Desarrollo de Estrategias en Salud
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2017-12-04
Enrollment: 244
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, double blind allocation concealment
Primary purpose: TREATMENT

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

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 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

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

Primary outcomes:
measure: Crying time
timeFrame: 21 days
Secondary outcomes:
measure: Preliminary crying time
timeFrame: Day 7 and 14
measure: Crying and fussing
timeFrame: 7,14 and 21 days
measure: Total responders
timeFrame: 7,14 and 21 days
measure: Impact on Quality of Life
timeFrame: 7, 14 and 21 days
measure: Maternal depression
timeFrame: 7, 14 and 21 days
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General Dr. Manuel Gea Gonzalez
state: Tlalpan
Study officials:
affiliation: Hospital General Dr. Manuel Gea Gonzalez
name: Pedro Gutierrez-Castrellon, DSc
role: PRINCIPAL_INVESTIGATOR
References: