Clinical Trial of L. Reuteri in Infantile Colic 2017

Not Applicable

• Conditions: Infantile Colic
• Interventions: Dietary Supplement: L. reuteri DSM 17938 in drops; Other: Placebo

• Registration Number: NCT03360253
• Lead Sponsor: Innovacion y Desarrollo de Estrategias en Salud

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

Study Timeline

• Study First Submitted: 2017-04-30
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-04
• Study Start: 2018-01-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-27
• Last Update Posted: 2019-07-30
• Primary Completion: 2019-11-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFormProb	L. reuteri DSM 17938 in drops	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
IFormPlacebo	Placebo	The placebo consists of an identical formulation except that the L. reuteri is not present
HMilkProb	L. reuteri DSM 17938 in drops	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
HMilkPlacebo	Placebo	The placebo consists of an identical formulation except that the L. reuteri is not present

Primary Outcome Measures

Name	Time	Method
Crying time	21 days	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.; 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 Outcome Measures

Name	Time	Method
Crying and fussing	7,14 and 21 days	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
Preliminary crying time	Day 7 and 14	Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group
Impact on Quality of Life	7, 14 and 21 days	Impact on Quality of Life measured by PedsQL-2.0-Family Impact Module AU2.0 spa-MX. Changes from baseline to days 7, 14 and 21
Total responders	7,14 and 21 days	Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study
Maternal depression	7, 14 and 21 days	Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)

Trial Locations

Locations (1)

Hospital General Dr. Manuel Gea Gonzalez; 🇲🇽 Mexico city, Tlalpan, Mexico