NCT03360253

Clinical Trial of L. Reuteri in Infantile Colic 2017

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Innovacion y Desarrollo de Estrategias en Salud · Academic / Other
• Sex: All
• Age: 1 Week – 9 Weeks
• Healthy volunteers: Not accepted

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

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri DSM 17938 in drops	L. reuteri DSM 17938 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
OTHER	Placebo	The placebo consists of an identical formulation except that the L. reuteri is not present

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-11-30
• Completion: 2020-01-30
• First posted: 2017-12-04
• Last updated: 2019-07-30

Locations

1 site across 1 country: Mexico