Skip to main content
OpenTrials
Completed

NCT Number: NCT04537494

PRobiotics for EVEry Newborn 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infantile

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

L. reuteri

Dietary Supplement

Probiotic

Other names: BioGaia

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Infant daily cry duration

    Time frame: Baseline

    Daily cry duration will be examined separately

  2. Infant daily cry duration

    Time frame: 6 weeks

    Daily cry duration will be examined separately

  3. Infant daily cry duration

    Time frame: 12 weeks

    Daily cry duration will be examined separately

  4. Infant daily fuss duration

    Time frame: Baseline, 6 and 12 weeks of age

    Daily fuss duration will be examined separately

  5. Infant daily fuss duration

    Time frame: Baseline

    Daily fuss duration will be examined separately

  6. Infant daily fuss duration

    Time frame: 6 weeks

    Daily fuss duration will be examined separately

  7. Infant colic

    Time frame: 12 weeks

    Daily cry/fuss of at least 180 minutes

  8. Infant daily sleep duration

    Time frame: Baseline

    Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. Gut microbial composition, diversity and function

    Time frame: Baseline

    Microbial composition, diversity and function will be measured in infant fecal samples.

  18. Gut microbial composition, diversity and function

    Time frame: 6 weeks

    Microbial composition, diversity and function will be measured in infant fecal samples.

  19. Gut microbial composition, diversity and function

    Time frame: 12 weeks

    Microbial composition, diversity and function will be measured in infant fecal samples.

  20. 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

  21. 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

  22. Adverse effects - growth/length

    Time frame: 8 weeks

    Infant growth (length) will be measured at scheduled health supervision visits

  23. Adverse effects - growth/weight

    Time frame: 8 weeks

    Infant growth (weight) will be measured at scheduled health supervision visits

  24. Adverse effects - growth/head circumference

    Time frame: 8 weeks

    Infant growth (head circumference) will be measured at scheduled health supervision visits

  25. Adverse effects - growth/length

    Time frame: 16 weeks

    Infant growth (length) will be measured at scheduled health supervision visits

  26. Adverse effects - growth/weight

    Time frame: 16 weeks

    Infant growth (weight) will be measured at scheduled health supervision visits

  27. Adverse effects - growth/head circumference

    Time frame: 16 weeks

    Infant growth (head circumference) will be measured at scheduled health supervision visits

  28. Health services utilization

    Time frame: Baseline

    Frequency of assessments

  29. Health services utilization

    Time frame: 6 weeks

    Frequency of assessments

  30. Health services utilization

    Time frame: 12 weeks

    Frequency of assessments

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 3, 2020
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.