NCT07347743 Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
| NCT ID | NCT07347743 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Colic |
| Study Type | INTERVENTIONAL |
| Enrollment | 768 participants |
| Start Date | 2026-01-31 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 768 participants in total. It began in 2026-01-31 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks. 2. Infant is healthy at the time of pre-examination. 3. Infant is aged between 1 and 14 days old at the time of inclusion. 4. Legal guardian(s) are able and willing to follow the study instructions 5. Infant is suitable for participation in the study according to the investigator/ study personnel 6. Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3). 7. Informed written consent given by parent / legal guardian Exclusion Criteria: 1. No legal guardian's command of any local language 2. 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) 3. Infant is suffering from congenital or acquired immunodeficiency 4. Infant is suffering from an infection at the time of pre-examination or previous 7 days 5. Infant is admitted post-partum to the neonatal intensive care unit 6. Infant is not suitable for participation in the study according to the study personnel´s opinion
Contact & Investigator
Koen Huysentruyt, Pediatric Gastroenterologist
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT07347743 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 14 Days, studying Colic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07347743 currently recruiting?
Yes, NCT07347743 is actively recruiting participants. Contact the research team at koen.huysentruyt@uzbrussel.be for enrollment information.
Where is the NCT07347743 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT07347743 clinical trial?
NCT07347743 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Koen Huysentruyt, Pediatric Gastroenterologist at Universitair Ziekenhuis Brussel. The trial plans to enroll 768 participants.