ClinicalTrials.gg
Sign In
Active, not recruitingNCT07190859Updated Oct 15, 2026

Evaluating the 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. Active, not recruiting at 4 sites in Bulgaria. 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 Active, not recruitingPrimary completion moved+2 moreGo to Updates ↓
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

Browse trials for

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

    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

    Change in mean crying and fussing time as assessed by the Baby's Day Diary

    Time frame: From baseline to Day 7

Secondary outcomes

  1. Crying and fussing time

    Change in mean crying and fussing time as assessed by the Baby's Day Diary

    Time frame: From baseline up to Day 21

  2. Number of responders

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

    Time frame: From baseline up to Day 21

  3. Family Quality of Life

    Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score This is a 36-item questionnaire, possible score 0-100, with higher score indicating a better outcome.

    Time frame: From baseline up to Day 21

  4. Sleeping time

    Change in mean sleeping time as assessed by Baby´s Day Diary

    Time frame: From baseline up to Day 21

  5. Maternal depression

    Change in maternal depression as assessed by the Edinburgh Postnatal Depression Scale Total Score The score range is 0-30 with higher score indicating a worse outcome.

    Time frame: From baseline up to Day 21

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 15, 2026
Primary completion
Feb 17, 2026→Oct 17, 2027
Oct 15, 2026
Study completion
Aug 30, 2026→Oct 30, 2027
Oct 15, 2026
Secondary outcomes
2 description edited
What changed in the outcomes
  • DescriptionFamily Quality of Life: how it is measured was reworded
  • DescriptionMaternal depression: how it is measured was reworded
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Active, not recruiting
    Primary completion Feb 17, 2026→Oct 17, 2027
    Study completion Aug 30, 2026→Oct 30, 2027
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionFamily Quality of Life: how it is measured was reworded
    • DescriptionMaternal depression: how it is measured was reworded
    + 3 other changes: verification date, contact details and site 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 ↗

10

Registry details

Key details

Study ID
NCT07190859
Lead sponsor
BioGaia AB
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Aug 4, 2025
Primary completion
Oct 17, 2027 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Oct 15, 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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lactobacillus reuteri

Other studies in this condition

Colic →

Other studies from this sponsor

BioGaia AB

Start the discussion