Status:
RECRUITING
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Lead Sponsor:
BioGaia AB
Conditions:
Infantile Colic
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
- Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
- The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
- Infant is considered healthy, in the opinion of the investigator following physical exam.
Exclusion
- 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.
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07190859
Start Date
August 4 2025
End Date
August 30 2026
Last Update
September 24 2025
Active Locations (4)
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1
UMHAT Deva Maria
Burgas, Bulgaria, 8127
2
Medical Centre Asklepiy OOD
Dupnitsa, Bulgaria, 2600
3
AIPSMP
Stara Zagora, Bulgaria, 6000
4
Ipsmp Eood
Stara Zagora, Bulgaria, 6000