Clinical Trial of L. Reuteri in Infantile Colic 2017

Infantile Colic Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360253
• Other study ID #: Colic2017
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2019
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: Patricia Vidal, MSc
• Phone: 525540003000
• Email: vidalv.patricia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: January 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city	Tlalpan

Sponsors (2)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud	BioGaia AB

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal depression	Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)	7, 14 and 21 days