NCT07347743Recruiting
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.
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 768 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- 31 Jan 2026
- Primary completion date
- May 2028
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07347743
What you commit to
- Study type: Interventional
- Planned participants: 768
- From 31 Jan 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
Other illness
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
Other
- No legal guardian's command of any local language
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
Who the study is looking for
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
- Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- Informed written consent given by parent / legal guardian
Age in the registry: 1 day to 14 days · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.