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
1 other identifier
interventional
244
1 country
1
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%)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedJuly 30, 2019
July 1, 2019
1.9 years
April 30, 2017
July 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Preliminary crying time
Day 7 and 14
Crying and fussing
7,14 and 21 days
Total responders
7,14 and 21 days
Impact on Quality of Life
7, 14 and 21 days
Maternal depression
7, 14 and 21 days
Study Arms (4)
HMilkProb
EXPERIMENTALL. 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 COMPARATORThe placebo consists of an identical formulation except that the L. reuteri is not present
IFormProb
EXPERIMENTALL. 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 COMPARATORThe placebo consists of an identical formulation except that the L. reuteri is not present
Interventions
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
The placebo consists of an identical formulation except that the L. reuteri is not present
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Innovacion y Desarrollo de Estrategias en Saludlead
- BioGaia ABcollaborator
Study Sites (1)
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, 14080, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Gutierrez-Castrellon, DSc
Hospital General Dr. Manuel Gea Gonzalez
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Children allocated on different arms will receive drops of probiotics or placebo. Both product are identical in appearence and flavor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc, DSc
Study Record Dates
First Submitted
April 30, 2017
First Posted
December 4, 2017
Study Start
January 1, 2018
Primary Completion
November 30, 2019
Study Completion
January 30, 2020
Last Updated
July 30, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share