PRobiotics for EVEry Newborn Trial (PREVENT)

May 14, 2025 updated by: Patricia Parkin, The Hospital for Sick Children

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Combined infant daily cry/fuss duration
Time Frame: Baseline
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
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant daily cry duration
Time Frame: Baseline
Daily cry duration will be examined separately
Baseline
Infant daily cry duration
Time Frame: 6 weeks
Daily cry duration will be examined separately
6 weeks
Infant daily cry duration
Time Frame: 12 weeks
Daily cry duration will be examined separately
12 weeks
Infant daily fuss duration
Time Frame: Baseline, 6 and 12 weeks of age
Daily fuss duration will be examined separately
Baseline, 6 and 12 weeks of age
Infant daily fuss duration
Time Frame: Baseline
Daily fuss duration will be examined separately
Baseline
Infant daily fuss duration
Time Frame: 6 weeks
Daily fuss duration will be examined separately
6 weeks
Infant colic
Time Frame: 12 weeks
Daily cry/fuss of at least 180 minutes
12 weeks
Infant daily sleep duration
Time Frame: Baseline
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Baseline
Infant daily sleep duration
Time Frame: 6 weeks
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
6 weeks
Infant daily sleep duration
Time Frame: 12 weeks
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
Time Frame: Baseline
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
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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
Time Frame: Baseline
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
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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
Time Frame: Baseline
Microbial composition, diversity and function will be measured in infant fecal samples.
Baseline
Gut microbial composition, diversity and function
Time Frame: 6 weeks
Microbial composition, diversity and function will be measured in infant fecal samples.
6 weeks
Gut microbial composition, diversity and function
Time Frame: 12 weeks
Microbial composition, diversity and function will be measured in infant fecal samples.
12 weeks
Adverse effects - digestive upset
Time Frame: 8 weeks
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
8 weeks
Adverse effects - digestive upset
Time Frame: 16 weeks
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
16 weeks
Adverse effects - growth/length
Time Frame: 8 weeks
Infant growth (length) will be measured at scheduled health supervision visits
8 weeks
Adverse effects - growth/weight
Time Frame: 8 weeks
Infant growth (weight) will be measured at scheduled health supervision visits
8 weeks
Adverse effects - growth/head circumference
Time Frame: 8 weeks
Infant growth (head circumference) will be measured at scheduled health supervision visits
8 weeks
Adverse effects - growth/length
Time Frame: 16 weeks
Infant growth (length) will be measured at scheduled health supervision visits
16 weeks
Adverse effects - growth/weight
Time Frame: 16 weeks
Infant growth (weight) will be measured at scheduled health supervision visits
16 weeks
Adverse effects - growth/head circumference
Time Frame: 16 weeks
Infant growth (head circumference) will be measured at scheduled health supervision visits
16 weeks
Health services utilization
Time Frame: Baseline
Frequency of assessments
Baseline
Health services utilization
Time Frame: 6 weeks
Frequency of assessments
6 weeks
Health services utilization
Time Frame: 12 weeks
Frequency of assessments
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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