Can a probiotic stop baby colic crying?
NCT ID NCT05512234
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether a probiotic called L. reuteri can reduce crying and fussing in infants with colic. About 102 breastfed babies aged 3-8 weeks will receive either the probiotic or placebo drops daily for 21 days. Parents will track crying times to see if the probiotic helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Limosilactobacillus reuteri (L. reuteri) probiotic drops
- What this could lead to
- If it works, this could provide a simple, natural way to ease colic symptoms in breastfed infants, reducing crying and fussing time.
- What could go wrong
- This is a small, early-stage trial with only 102 infants. The probiotic may not work better than placebo, and results may not apply to all babies with colic.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 8 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 3-8 weeks at screening. 2. Gestational age 37+0 weeks - 42+0 weeks at birth. 3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides. 4. Parents/caregivers/legal guardians are \>18 years. 5. Exclusively or predominantly breastfed infants (\> 50 % breast fed). 6. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.). 7. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires. 8. Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time. 9. Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator. 10. Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study. 11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 8), and Visit 6 (Day 22). 12. Infant is considered healthy, in the opinion of the investigator following physical exam. Exclusion criteria 1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis). 2. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/legal guardians. 3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease. 4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period. 5. Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period. 6. Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlantia Clinical Trials
RECRUITINGCork, Ireland
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Clinical Trail Consultants AB
RECRUITINGUppsala, Sweden
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