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CompletedNCT06462651Updated Mar 19, 2026

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

An interventional study of L. reuteri and Placebo in Infantile Colic, sponsored by BioGaia AB. Completed at 1 site in Italy. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-03-19.

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Weeks to 12 Weeks
Sex
All
01

Study summary

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

02

Conditions studied

  • Infantile Colic

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03

In context

Colic

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

This study's enrollment of 50 is below 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

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 3 (Day 8), and Visit 4 (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
50 participants (actual)

Study arms

  • Experimental
    L. reuteri

    Dietary Supplement: L. reuteri

    Dietary Supplement: L. reuteri

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementL. reuteri

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

  • Dietary supplementPlacebo

    Supplementation with identical drops without L. reuteri once daily for 21 consecutive days

06

What researchers measure

Primary outcomes

  1. Crying and fussing time

    To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic.

    Time frame: [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´s Day Diary

    Time frame: [Time Frame: From baseline up to Day 21]

  2. Crying time

    Change in mean daily crying time measured by Baby´s Day Diary

    Time frame: [Time Frame: From baseline up to Day 21]

  3. Number of responders

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

    Time frame: [Time Frame: From baseline up to 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: [Time Frame: From baseline up to Day 21]

  5. Sleeping time

    Change in mean sleeping time measured by Baby´s Day Diary

    Time frame: [Time Frame: From baseline up to Day 21]

  6. Maternal depression

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

    Time frame: [Time Frame: From baseline up to Day 21]

07

Study locations

1 site
  • University of Salento, University Hospital Vito Fazzi Lecce
    Lecce, LE 73100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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 Jun 2025 to primary completion in Mar 2026, 9 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 9 months is below that.

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

Registered
Jun 12, 2024
First posted
Jun 17, 2024
StartActual
Jun 9, 2025
Primary completionActual
Mar 15, 2026
CompletionActual
Mar 15, 2026
Last update
Mar 19, 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.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06462651
Lead sponsor
BioGaia AB
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
Jun 9, 2025
Primary completion
Mar 15, 2026
Completion
Mar 15, 2026
Last update
Mar 19, 2026

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 Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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