NCT04537494

Brief Summary

The aim of the study is to compare prevention (oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks) with treatment-as-needed (supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age). This is a single site pilot study to assess feasibility for a full trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 27, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

January 27, 2020

Last Update Submit

May 14, 2025

Conditions

ColicInfantile

Keywords

ColicProbioticInfant

Outcome Measures

Primary Outcomes (3)

  • Combined infant daily cry/fuss duration

    The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.

    Baseline

  • Combined infant daily cry/fuss duration

    The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.

    6 weeks

  • Combined infant daily cry/fuss duration

    The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.

    12 weeks

Secondary Outcomes (30)

  • Infant daily cry duration

    Baseline

  • Infant daily cry duration

    6 weeks

  • Infant daily cry duration

    12 weeks

  • Infant daily fuss duration

    Baseline, 6 and 12 weeks of age

  • Infant daily fuss duration

    Baseline

  • +25 more secondary outcomes

Study Arms (4)

Prevention (Randomized)

ACTIVE COMPARATOR

Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks

Dietary Supplement: L. reuteri

Treatment-as-needed (Randomized)

OTHER

Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age

Dietary Supplement: L. reuteri

Prevention (Parent Preference)

ACTIVE COMPARATOR

Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks

Dietary Supplement: L. reuteri

Treatment-as-needed (Parent Preference)

OTHER

Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age

Dietary Supplement: L. reuteri

Interventions

L. reuteriDIETARY_SUPPLEMENT

Probiotic

Also known as: BioGaia
Prevention (Parent Preference)Prevention (Randomized)Treatment-as-needed (Parent Preference)Treatment-as-needed (Randomized)

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 7 days of age
  • term (37 to 41 weeks)
  • breast or formula fed
  • birth weight \> 2500 grams
  • parental consent

You may not qualify if:

  • congenital or other medical disorders
  • parents unable to communicate in English or French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Patricia Parkin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

  • Patricia Li, MD

    The Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
For the 2 Randomized arms, all parties were masked. For the 2 Parent Preference arms, all parties were unmasked (open label)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Senior Associate Scientist, Staff Pediatrician

Study Record Dates

First Submitted

January 27, 2020

First Posted

September 3, 2020

Study Start

December 1, 2021

Primary Completion

September 8, 2023

Study Completion

September 8, 2023

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations

CA(1)