Limosilactobacillus reuteri to reduce crying and fussing in infants with colic

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

This will test if the probiotic Limosilactobacillus reuteri can reduce daily crying and fussing in predominantly breastfed infants aged 3–12 weeks with colic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 3 Weeks to 12 Weeks
• Sex: All
• Sponsor: BioGaia AB (Industry-sponsored)
• Locations: 4 sites (Burgas and 3 other locations)
• Trial ID: NCT07190859 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled parallel-group study in infants diagnosed with infantile colic by Rome IV criteria. Eligible term infants aged 3–12 weeks who are predominantly breastfed are randomized to receive oral L. reuteri or matching placebo while caregivers keep a daily diary of crying and fussing. The primary outcome is change in daily crying and fussing time, recorded by parents and confirmed at study visits. Participants and study staff are masked to assignment to limit bias and the intervention is compared directly to placebo.

Who should consider this trial

Good fit: Term infants aged 3–12 weeks, predominantly breastfed (>50%), with colic meeting Rome IV criteria and parents able to complete daily diaries are ideal candidates.

Not a fit: Infants who are primarily formula-fed, born preterm, outside the 3–12 week age range, or whose symptoms stem from an identifiable medical condition may be less likely to benefit.

Why it matters

Potential benefit: If effective, the probiotic could reduce daily crying and fussing and improve comfort for infants and their caregivers.

How similar studies have performed: Previous randomized trials of L. reuteri have reported reduced crying in predominantly breastfed infants but results have been inconsistent, especially in formula-fed populations.

Eligibility criteria

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 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 3 (Day 8), and Visit 4 (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.

Where this trial is running

Burgas and 3 other locations

• UMHAT Deva Maria — Burgas, Bulgaria (Recruiting)
• Medical Centre Asklepiy OOD — Dupnitsa, Bulgaria (Recruiting)
• Aipsmp — Stara Zagora, Bulgaria (Recruiting)
• Ipsmp Eood — Stara Zagora, Bulgaria (Recruiting)

Study contacts

• Study coordinator: Sanna Nyström, PhD

Conditions Infantile Colic