ColicPREVENTNCT04537494

PRobiotics for EVEry Newborn Trial

A study testing L. reuteri in people with Colic and Infantile, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 7 daysHealthy volunteers can take part
Conditions the study is for: Colic, Infantile
What is being tested?: L. reuteri
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: 1 Dec 2021to 8 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 7 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Colic, Infantile
Being tested: L. reuteri
Keywords: Colic, Probiotic, Infant
Medical subject headings: Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L. reuteriDietary supplement
Also called BioGaia
Probiotic

Study groups in NCT04537494
Study group	Role	What they receive
Prevention (Randomized)	Active comparator	Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: L. reuteri

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 12 weeks

Secondary outcomes (30)

Infant daily cry duration
Daily cry duration will be examined separately
Measured: Baseline
Infant daily cry duration
Daily cry duration will be examined separately
Measured: 6 weeks
Infant daily cry duration
Daily cry duration will be examined separately
Measured: 12 weeks
Infant daily fuss duration
Daily fuss duration will be examined separately
Measured: Baseline, 6 and 12 weeks of age
Infant daily fuss duration
Daily fuss duration will be examined separately
Measured: Baseline
Infant daily fuss duration
Daily fuss duration will be examined separately
Measured: 6 weeks
Infant colic
Daily cry/fuss of at least 180 minutes
Measured: 12 weeks
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Measured: Baseline
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Measured: 6 weeks
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 weeks
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Measured: Baseline
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Measured: 6 weeks
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Measured: 12 weeks
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Measured: 8 weeks
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Measured: 16 weeks
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Measured: 8 weeks
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Measured: 8 weeks
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Measured: 8 weeks
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Measured: 16 weeks
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Measured: 16 weeks
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Measured: 16 weeks
Health services utilization
Frequency of assessments
Measured: Baseline
Health services utilization
Frequency of assessments
Measured: 6 weeks
Health services utilization
Frequency of assessments
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20218 Sep 2023

First posted3 Sep 2020
Study start1 Dec 2021
Primary completion8 Sep 2023
Study completion8 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ColicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04537494
Sponsor's protocol ID: 1000064700
Acronym: PREVENT
Status last verified: May 2025
First submitted: 27 Jan 2020
Last updated: 18 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Infant Colic, Atopic Dermatitis

All Colic trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
ClinicalTrials.gov ID: NCT04537494
Acronym / sponsor ID: PREVENT / 1000064700
Conditions: Colic, Infantile
Keywords: Colic, Probiotic, Infant
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: The Hospital for Sick ChildrenUniversity, hospital or other
Study start: 1 Dec 2021 (actual)
Primary completion: 8 Sep 2023 (actual)
Study completion: 8 Sep 2023 (actual)
First posted: 3 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Prevention (Randomized)	Active comparator	Dietary Supplement: L. reuteriOral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Treatment-as-needed (Randomized)	Other	Dietary Supplement: L. reuteriSupplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age
Prevention (Parent Preference)	Active comparator	Dietary Supplement: L. reuteriOral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Treatment-as-needed (Parent Preference)	Other	Dietary Supplement: L. reuteriSupplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age

Who may qualify

Ages: 1 day to 7 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L. reuteriAlso: BioGaiaProbiotic	Dietary supplement	Prevention (Parent Preference), Prevention (Randomized), Treatment-as-needed (Parent Preference), Treatment-as-needed (Randomized)

Primary outcome

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.
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.
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.

30 secondary outcomes

Infant daily cry duration
Time frame: Baseline
Infant daily cry duration
Time frame: 6 weeks
Infant daily cry duration
Time frame: 12 weeks
Infant daily fuss duration
Time frame: Baseline, 6 and 12 weeks of age
Infant daily fuss duration
Time frame: Baseline
Infant daily fuss duration
Time frame: 6 weeks
Infant colic
Time frame: 12 weeks
Infant daily sleep duration
Time frame: Baseline
Infant daily sleep duration
Time frame: 6 weeks
Infant daily sleep duration
Time frame: 12 weeks
Parent (female and male) mental health
Time frame: Baseline
Parent (female and male) mental health
Time frame: 6 weeks
Parent (female and male) mental health
Time frame: 12 weeks
Parent (female and male) fatigue
Time frame: Baseline
Parent (female and male) fatigue
Time frame: 6 weeks
Parent (female and male) fatigue
Time frame: 12 weeks
Gut microbial composition, diversity and function
Time frame: Baseline
Gut microbial composition, diversity and function
Time frame: 6 weeks
Gut microbial composition, diversity and function
Time frame: 12 weeks
Adverse effects - digestive upset
Time frame: 8 weeks
Adverse effects - digestive upset
Time frame: 16 weeks
Adverse effects - growth/length
Time frame: 8 weeks
Adverse effects - growth/weight
Time frame: 8 weeks
Adverse effects - growth/head circumference
Time frame: 8 weeks
Adverse effects - growth/length
Time frame: 16 weeks
Adverse effects - growth/weight
Time frame: 16 weeks
Adverse effects - growth/head circumference
Time frame: 16 weeks
Health services utilization
Time frame: Baseline
Health services utilization
Time frame: 6 weeks
Health services utilization
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.

Related trials for Colic

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Infant Colic, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia Parkin, MD principal investigator

The Hospital for Sick Children

Patricia Li, MD principal investigator

The Research Institute of the McGill University Health Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing L. reuteri in people with Colic and Infantile, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined infant daily cry/fuss duration (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.