An interventional study of L. reuteri in Colic and Infantile, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 1 Day to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Prevention
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.
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 32 is below the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Dietary Supplement: L. reuteri
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
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Dietary Supplement: L. reuteri
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
Also known as: BioGaia
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Infant daily cry duration
Daily cry duration will be examined separately
Time frame: Baseline
Infant daily cry duration
Daily cry duration will be examined separately
Time frame: 6 weeks
Infant daily cry duration
Daily cry duration will be examined separately
Time frame: 12 weeks
Infant daily fuss duration
Daily fuss duration will be examined separately
Time frame: Baseline, 6 and 12 weeks of age
Infant daily fuss duration
Daily fuss duration will be examined separately
Time frame: Baseline
Infant daily fuss duration
Daily fuss duration will be examined separately
Time frame: 6 weeks
Infant colic
Daily cry/fuss of at least 180 minutes
Time frame: 12 weeks
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time frame: Baseline
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time frame: 6 weeks
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 12 weeks
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Time frame: Baseline
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Time frame: 6 weeks
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Time frame: 12 weeks
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Time frame: 8 weeks
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Time frame: 16 weeks
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Time frame: 8 weeks
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Time frame: 8 weeks
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Time frame: 8 weeks
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Time frame: 16 weeks
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Time frame: 16 weeks
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Time frame: 16 weeks
Health services utilization
Frequency of assessments
Time frame: Baseline
Health services utilization
Frequency of assessments
Time frame: 6 weeks
Health services utilization
Frequency of assessments
Time frame: 12 weeks
Ran from Dec 2021 to primary completion in Sep 2023, 21 months.
Of 32 non-industry interventional studies with no phase under Colic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's 21 months is above that.
Counting every sponsor, half of 44 studies reached it within 21 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactobacillus reuteri
The Hospital for Sick Children →