PRobiotics for EVEry Newborn Trial (PREVENT)

PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Colic; Infantile
• Intervention / Treatment: Dietary supplement: L. reuteri

Detailed Description

One in five infants experience colic, defined as recurrent and prolonged episodes of crying and fussing with no obvious cause in healthy infants less than 5 months of age. There is evidence to support the role of the probiotic L. reuteri for treatment of colic in breastfed babies and for prevention of colic. However, these two options (prevention vs treatment-as-needed) have not been previously compared head-to-head. The study aims determine if oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks (prevention) is superior to treatment-as-needed, as measured by daily cry/fuss duration at 6 and 12 weeks of age.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 1 to 7 days of age
2. term (37 to 41 weeks)
3. breast or formula fed
4. birth weight > 2500 grams
5. parental consent

Exclusion Criteria:

1. congenital or other medical disorders
2. parents unable to communicate in English or French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prevention (Randomized); Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks	Dietary supplement: L. reuteri; Probiotic; Other Names: BioGaia
Other: Treatment-as-needed (Randomized); 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; Probiotic; Other Names: BioGaia
Active Comparator: Prevention (Parent Preference); Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks	Dietary supplement: L. reuteri; Probiotic; Other Names: BioGaia
Other: Treatment-as-needed (Parent Preference); 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; Probiotic; Other Names: BioGaia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant daily cry duration	Daily cry duration will be examined separately	Baseline
Infant daily cry duration	Daily cry duration will be examined separately	6 weeks
Infant daily cry duration	Daily cry duration will be examined separately	12 weeks
Infant daily fuss duration	Daily fuss duration will be examined separately	Baseline, 6 and 12 weeks of age
Infant daily fuss duration	Daily fuss duration will be examined separately	Baseline
Infant daily fuss duration	Daily fuss duration will be examined separately	6 weeks
Infant colic	Daily cry/fuss of at least 180 minutes	12 weeks
Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	Baseline
Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	6 weeks
Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	12 weeks
Parent (female and male) mental health	Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scores range between 0 and 30 and higher scores mean worse outcome.	Baseline
Parent (female and male) mental health	Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scores range between 0 and 30 and higher score means worse outcome.	6 weeks
Parent (female and male) mental health	Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scoring is between o and 30 and higher score means worse outcome.	12 weeks
Parent (female and male) fatigue	Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome	Baseline
Parent (female and male) fatigue	Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome.	6 weeks
Parent (female and male) fatigue	Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome	12 weeks
Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	Baseline
Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	6 weeks
Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	12 weeks
Adverse effects - digestive upset	Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary	8 weeks
Adverse effects - digestive upset	Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary	16 weeks
Adverse effects - growth/length	Infant growth (length) will be measured at scheduled health supervision visits	8 weeks
Adverse effects - growth/weight	Infant growth (weight) will be measured at scheduled health supervision visits	8 weeks
Adverse effects - growth/head circumference	Infant growth (head circumference) will be measured at scheduled health supervision visits	8 weeks
Adverse effects - growth/length	Infant growth (length) will be measured at scheduled health supervision visits	16 weeks
Adverse effects - growth/weight	Infant growth (weight) will be measured at scheduled health supervision visits	16 weeks
Adverse effects - growth/head circumference	Infant growth (head circumference) will be measured at scheduled health supervision visits	16 weeks
Health services utilization	Frequency of assessments	Baseline
Health services utilization	Frequency of assessments	6 weeks
Health services utilization	Frequency of assessments	12 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Patricia Li, MD, The Research Institute of the McGill University Health Centre; Principal Investigator: Patricia Parkin, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Infant; Probiotic; Colic
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 1000064700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No