Actively Recruiting
A Double-blind, Randomised, Placebo-controlled Study Evaluating Probiotic Limosilactobacillus Reuteri on Crying and Fussing Time in Infants With Colic
Led by BioGaia AB · Updated on 2025-09-24
50
Participants Needed
4
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of the probiotic Limosilactobacillus reuteri (L. reuteri) on reducing crying and fussing time in infants with colic. This is a double-blind, randomized, placebo-controlled study designed to better understand how this dietary supplement may influence infantile colic symptoms. The primary focus is to measure changes in crying and fussing time, which are common concerns for infants with colic and their families. In this study, infants will be randomly assigned to receive either L. reuteri drops or a placebo once daily for 21 consecutive days. Both groups receive identical-looking drops to maintain the study's blindness. The trial includes multiple visits during the treatment period and monitors various outcomes such as crying and fussing time, family quality of life, sleeping time, and maternal depression. Participants will be involved in regular visits on Day 0, Day 8, and Day 22, during which physical exams and assessments will be performed. Parents or caregivers will complete diaries and questionnaires to track the infant's crying and fussing patterns, sleep, and overall family impact. The main outcome measured is the change in crying and fussing time from baseline to Day 7, with additional follow-up until Day 21. Safety and health of the infant will be monitored throughout the study period.
CONDITIONS
Brief Title
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant aged between 3 and 12 weeks at screening
- Born at gestational age 37+0 to 42+0 weeks
- Birth weight appropriate or large for gestational age based on WHO percentiles
- Parent or caregiver is over 18 years old
- Infant is exclusively or predominantly breastfed (more than 50%)
- Willing to maintain current feeding patterns without changes
- Parent or caregiver able and willing to fill out study diaries and questionnaires
- Infantile colic diagnosed by Rome IV criteria, confirmed by diary showing 3+ hours of crying/fussing in at least one 24-hour period
- Parent or caregiver able to understand and comply with study requirements
- Parent or caregiver willing and able to give informed consent
- Mother willing to attend study visits on Day 0, Day 8, and Day 22
- Infant considered healthy based on physical exam by investigator
You will not qualify if you...
- Infants with severe gastroesophageal reflux (vomiting more than a teaspoon over 8 times daily, projectile, bilious, or bloody)
- Infants with failure to thrive, growth problems, blood in stools, diarrhea, or fever
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, or liver disease
- Infants exposed to probiotics within 7 days before screening or during the study
- Infants exposed to oral or systemic antibiotics within 7 days before screening or during the study
- Infants who have used medications or therapies aimed at relieving colic, including proton pump inhibitors, within 7 days before screening or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants receive daily supplementation with either L. reuteri or placebo drops for 21 consecutive days.
3 visits (Day 0, Day 8, and Day 22)
Trial Site Locations
Total: 4 locations
1
UMHAT Deva Maria
Burgas, Bulgaria, 8127
Actively Recruiting
2
Medical Centre Asklepiy OOD
Dupnitsa, Bulgaria, 2600
Actively Recruiting
3
AIPSMP
Stara Zagora, Bulgaria, 6000
Actively Recruiting
4
Ipsmp Eood
Stara Zagora, Bulgaria, 6000
Actively Recruiting
Research Team
S
Sanna Nyström, PhD
P
Petra J Lierud
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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