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

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

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%)

Study Overview

• Status: Unknown
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: L. reuteri DSM 17938 in drops; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Vidal, MSc; Phone Number: 3717 525540003000; Email: vidalv.patricia@gmail.com
• Study Contact Backup: Name: Monica Rodriguez, MSc; Phone Number: 3717 525540003000; Email: mon.medley@gmail.com

Study Locations

• Mexico
  • Tlalpan
    • Mexico city, Tlalpan, Mexico, 14080
      • Recruiting
      • Hospital General Dr. Manuel Gea González
      • Contact: Patricia Vidal, MSc; Phone Number: 3717 525540003000; Email: vidalv.patricia@gmail.com
      • Contact: Monica Rodriguez, MSc; Phone Number: 3717 525540003000; Email: mon.medley@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HMilkProb; 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	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
PLACEBO_COMPARATOR: HMilkPlacebo; The placebo consists of an identical formulation except that the L. reuteri is not present	Other: Placebo; The placebo consists of an identical formulation except that the L. reuteri is not present
EXPERIMENTAL: IFormProb; 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	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
PLACEBO_COMPARATOR: IFormPlacebo; The placebo consists of an identical formulation except that the L. reuteri is not present	Other: Placebo; The placebo consists of an identical formulation except that the L. reuteri is not present

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying time	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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary crying time	Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group	Day 7 and 14
Crying and fussing	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	7,14 and 21 days
Total responders	Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study	7,14 and 21 days
Impact on Quality of Life	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	7, 14 and 21 days
Maternal depression	Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)	7, 14 and 21 days

Collaborators and Investigators

• Sponsor: Innovacion y Desarrollo de Estrategias en Salud
• Collaborators: BioGaia AB
• Investigators: Principal Investigator: Pedro Gutierrez-Castrellon, DSc, Hospital General Dr. Manuel Gea González

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): January 30, 2020

Study Registration Dates

• First Submitted: April 30, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): December 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 27, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: Colic2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No