NCT07347743

Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.

Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 768 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.

Detailed description

This study is a double-blind, randomized, placebo-controlled trial conducted at UZ Brussel to evaluate the safety and preventive efficacy of a dietary supplement containing two probiotic strains of Limosilactobacillus reuteri on excessive crying and the development of infantile colic in healthy newborns. Recent systematic reviews and meta-analyses have shown that supplementation with certain strains of L. reuteri significantly reduces crying and fussing time in infants. A novel formulation combining those strains was developed to achieve a potentially enhanced effect on infant distress symptoms. This study investigates whether early supplementation, initiated within the first week of life, is safe and effective during the first three months of life. Healthy, full-term infants (≥37 weeks' gestation) aged 1-14 days at inclusion are eligible. Participants are randomized to receive either placebo plus vitamin D (400 IU) or L. reuteri plus vitamin D (400 IU) for a maximum of 98 days, until approximately 3 months of age. Study visits include a baseline visit (day 1-14), a midway visit at 6 weeks, an end-of-intervention visit at 3 months, and a long-term follow-up at 1 year. Additional telephone contacts are triggered by infant day diaries. The primary outcomes are peak crying and fussing time at 6 weeks of age and the occurrence of infantile colic during the first 3 months of life. Secondary outcomes include infant quality of life (ITQOL™), parental stress, parental satisfaction, crying and fussiness patterns, and the presence of atopic dermatitis. Exploratory outcomes assess changes in the intestinal microbiome, stool characteristics, biomarkers, growth, and allergy-related parameters. The primary hypothesis is that daily supplementation with the two strains of L. reuteri reduces the incidence of infantile colic and peak crying time at 6 weeks. Secondary hypotheses propose microbiome modulation leading to reduced distress, improved infant quality of life, and lower parental stress.

Conditions

• Colic
• Healthy Infants
• Eczema Atopic Dermatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Two probiotic Limosilactobacillus reuteri strains	Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D
DIETARY_SUPPLEMENT	Placebo	Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2026-01-16
• Last updated: 2026-02-19

Locations

1 site across 1 country: Belgium