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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Colic, Infantile

In brief

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.

Key facts

Study ID

NCT05512234

Run by

BioGaia AB

People needed

102

Starts

2022-07-13

Expected to finish

2025-10-30

Last updated by the study team

2025-09-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 3-8 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 4 (Day 8), and Visit 6 (Day 22).
• Infant is considered healthy, in the opinion of the investigator following physical exam.

You may not qualify if…

• 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.

Where it is running

• Atlantia Clinical Trials — Cork, Ireland (enrolling)
• Clinical Trail Consultants AB — Uppsala, Sweden (enrolling)

Full record on ClinicalTrials.gov

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