Actively Recruiting
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
Led by BioGaia AB · Updated on 2025-09-22
102
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
Sponsors
B
BioGaia AB
Lead Sponsor
A
Atlantia Food Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 3-8 weeks at screening.
- Gestational age 37+0 weeks to 42+0 weeks at birth.
- Birth weight appropriate for gestational age (AGA) or large for gestational age (LGA) based on WHO weight-for-age percentiles.
- Parents or caregivers are over 18 years old.
- Exclusively or predominantly breastfed infants (more than 50% breastfed).
- Willingness to maintain current feeding patterns.
- Parents or caregivers ready and able to complete study diaries and questionnaires.
- Infantile colic diagnosed by Rome IV criteria with at least one 24-hour period showing 3 or more hours of crying/fussing.
- Parents or caregivers able to understand and comply with study requirements.
- Parents or caregivers willing and able to give informed consent.
- Mother willing to attend scheduled visits on Day 0, Day 8, and Day 22.
- Infant considered healthy by investigator after physical exam.
You will not qualify if you...
- Infants with severe gastroesophageal reflux (vomiting more than a teaspoon of milk over 8 times daily, projectile, bilious, or bloody vomiting).
- Infants with failure to thrive, intrauterine growth retardation, blood in stools, diarrhea (more than 12 watery stools daily if breastfed, more than 5 if partially breastfed), or fever (38.0 degrees Celsius).
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, or liver disease.
- Infants exposed to probiotics in the 7 days before screening or during the study.
- Infants exposed to oral or systemic antibiotics in the 7 days before screening or during the study.
- Infants using medications or therapies for colic relief, including proton pump inhibitors, in the 7 days before screening or during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Atlantia Clinical Trials
Cork, Ireland
Actively Recruiting
2
Clinical Trail Consultants AB
Uppsala, Sweden
Actively Recruiting
Research Team
C
Caroline Linninge, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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