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Recruiting Not applicable

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

NCT05512234 · tracked via the Priya Life Science Sweden tracker
Sponsor
Phase
Not applicable
Started
2022-07-13
Last updated
2025-09-22

Condition(s) studied

Colic, Infantile

Investigational drug(s) / intervention(s)

L. reuteriPlacebo

L. reuteri: Dietary supplementation with drops containing L. reuteri once daily for 21 consecutive days

Placebo: Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

Study summary

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.

Eligibility

Sex
ALL
Min age
3 Weeks
Max age
8 Weeks
Healthy volunteers
No
Inclusion Criteria: 1. Aged between 3-8 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 4 (Day 8), and Visit 6 (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.

Primary outcome measure(s)

  • Crying and fussing time — From baseline to Day 7
    Change in daily crying and fussing time measured by Baby Day Diary

Trial sites (2)

FacilityCityRegionStatus
Atlantia Clinical Trials Cork Ireland Recruiting
Clinical Trail Consultants AB Uppsala Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05512234 on ClinicalTrials.gov ↗ ← All trials in Sweden