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

Primary Purpose

Infantile Colic

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
L. reuteri DSM 17938 in drops
Placebo
Sponsored by
Innovacion y Desarrollo de Estrategias en Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic

Eligibility Criteria

1 Week - 9 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital General Dr. Manuel Gea GonzalezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

HMilkProb

HMilkPlacebo

IFormProb

IFormPlacebo

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Preliminary crying time
Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group
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
Total responders
Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study
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
Maternal depression
Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)

Full Information

First Posted
April 30, 2017
Last Updated
July 27, 2019
Sponsor
Innovacion y Desarrollo de Estrategias en Salud
Collaborators
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT03360253
Brief Title
Clinical Trial of L. Reuteri in Infantile Colic 2017
Acronym
Colic2017
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Innovacion y Desarrollo de Estrategias en Salud
Collaborators
BioGaia AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, double blind allocation concealment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Children allocated on different arms will receive drops of probiotics or placebo. Both product are identical in appearence and flavor
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMilkProb
Arm Type
Experimental
Arm 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
Arm Title
HMilkPlacebo
Arm Type
Placebo Comparator
Arm Description
The placebo consists of an identical formulation except that the L. reuteri is not present
Arm Title
IFormProb
Arm Type
Experimental
Arm 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
Arm Title
IFormPlacebo
Arm Type
Placebo Comparator
Arm Description
The placebo consists of an identical formulation except that the L. reuteri is not present
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri DSM 17938 in drops
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo consists of an identical formulation except that the L. reuteri is not present
Primary Outcome Measure Information:
Title
Crying time
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Preliminary crying time
Description
Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group
Time Frame
Day 7 and 14
Title
Crying and fussing
Description
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
Time Frame
7,14 and 21 days
Title
Total responders
Description
Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study
Time Frame
7,14 and 21 days
Title
Impact on Quality of Life
Description
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
Time Frame
7, 14 and 21 days
Title
Maternal depression
Description
Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
7, 14 and 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
9 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Vidal, MSc
Phone
525540003000
Ext
3717
Email
vidalv.patricia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Rodriguez, MSc
Phone
525540003000
Ext
3717
Email
mon.medley@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Gutierrez-Castrellon, DSc
Organizational Affiliation
Hospital General Dr. Manuel Gea Gonzalez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Dr. Manuel Gea Gonzalez
City
Mexico city
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Vidal, MSc
Phone
525540003000
Ext
3717
Email
vidalv.patricia@gmail.com
First Name & Middle Initial & Last Name & Degree
Monica Rodriguez, MSc
Phone
525540003000
Ext
3717
Email
mon.medley@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Trial of L. Reuteri in Infantile Colic 2017

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