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CompletedNCT05512234Updated Oct 15, 2026

Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic

An interventional study of L. reuteri and Placebo in Colic, Infantile, sponsored by BioGaia AB. Completed at 3 sites in 3 countries. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by BioGaia AB · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Now CompletedFirst site in Mexico+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
3 Weeks to 12 Weeks
Sex
All
01

Study summary

This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.

Read the detailed description

Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.

Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.

02

Conditions studied

  • Colic, Infantile

Browse trials for

Keywords

  • Colic
  • L. reuteri
03

In context

Colic

127 studies on the registry are indexed under Colic; 18 are open to participants now.

This study's enrollment of 102 is above the median of 76 across 110 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

BioGaia AB is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 15, 2026. See what changed

Ages eligible
3 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Aged between 3-12 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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    L. reuteri

    5 drops administered once daily for 21 days

    Dietary Supplement: L. reuteri

  • Placebo comparator
    Placebo

    5 drops administered once daily for 21 days

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementL. reuteri

    Dietary supplementation with drops containing L. reuteri once daily for 21 consecutive days

  • Dietary supplementPlacebo

    Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

06

What researchers measure

Primary outcomes

  1. Crying and fussing time

    Change in daily crying and fussing time measured by Baby Day Diary

    Time frame: From baseline to Day 7

Secondary outcomes

  1. Crying and fussing time

    Change in mean daily crying and fussing time measured by Baby Day Diary

    Time frame: From baseline to Day 3, Day 5, Day 14, Day 21

  2. Crying time

    Change in mean daily crying time measured by Baby Day Diary

    Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21

  3. Number of responders

    Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline

    Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21

  4. Family quality of life (family QoL)

    Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score

    Time frame: From baseline to Day 7 and Day 21

  5. Sleeping time

    Change in mean sleeping time measured by Baby Day Diary

    Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21

  6. Maternal depression

    Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score

    Time frame: From baseline to Day 7 and Day 21

07

Study locations

3 sites
  • Atlantia Clinical Trials
    Cork, Ireland
  • Innovación y Desarrollo en Ciencias de la Salud SRL de CV
    Mexico City, 14090, Mexico
  • Clinical Trail Consultants AB
    Uppsala, Sweden
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Sep 2025, 37 months.

Of 44 interventional studies with no phase under Colic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 37 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Oct 2025 → Sep 2025 and completion Oct 2025 → Sep 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2022
First posted
Aug 23, 2022
StartActual
Jul 13, 2022
Primary completionActual
Sep 10, 2025was Oct 2025
CompletionActual
Sep 10, 2025was Oct 2025
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 15, 2026
Sites
1 site added — first site in Mexico
Show site
  • Innovación y Desarrollo en Ciencias de la Salud SRL de CV · Mexico City, Mexico
Oct 15, 2026
Primary completion
Oct 30, 2025→Sep 10, 2025 (actual)
Oct 15, 2026
Study completion
Oct 30, 2025→Sep 10, 2025 (actual)
Oct 15, 2026
Eligibility
Maximum age 8 Weeks→12 Weeks; 1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedAged between 3-812 weeks at screening.
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Completed
    1 site added — first site in Mexico
    Show site
    • Innovación y Desarrollo en Ciencias de la Salud SRL de CV · Mexico City, Mexico
    Primary completion Oct 30, 2025→Sep 10, 2025 (now actual)
    Study completion Oct 30, 2025→Sep 10, 2025 (now actual)
    Eligibility Maximum age 8 Weeks→12 Weeks; 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedAged between 3-812 weeks at screening.
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05512234
Lead sponsor
BioGaia AB
Collaborators
Atlantia Food Clinical Trials, CTC Clinical Trial Consultants AB
Responsible party
Sponsor
First posted
Aug 23, 2022
Start date
Jul 13, 2022
Primary completion
Sep 10, 2025
Completion
Sep 10, 2025
Last update
Oct 15, 2026

Study contacts

Jenny Palming, PhD
study director · BioGaia AB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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