CompletedNot Applicable

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

Italy50 participantsStarted 2025-06-09

Plain-language 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.

Who can participate

Age range3 Weeks – 12 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged between 3-12 weeks at screening.
✓. Gestational age 37+0 weeks - 42+0 weeks at birth.
✓. 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.
✓. Parents/caregivers/legal guardians are \>18 years.
✓. Exclusively or predominantly breastfed infants (\> 50 % breast fed).
✓. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
✓. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
✓. 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.

Exclusion criteria

✕. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis).
✕. 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.
✕. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
✕. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
✕. Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
✕. 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.

What they're measuring

Crying and fussing time

Timeframe: [Time Frame: From baseline to Day 7]

Trial details

NCT IDNCT06462651

SponsorBioGaia AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-15

View on ClinicalTrials.gov More Infantile Colic trials