Preventing excessive crying and colic in newborns with a probiotic supplement of two L. reuteri strains
Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
This will try giving healthy newborns a dietary supplement containing two L. reuteri probiotic strains plus vitamin D during their first three months to see if it reduces excessive crying and infantile colic compared with a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 768 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette, Brussels Capital) |
| Trial ID | NCT07347743 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled study at UZ Brussel that enrolls healthy full-term infants aged 1–14 days to receive either a two-strain Limosilactobacillus reuteri supplement plus vitamin D or placebo plus vitamin D for up to about 98 days. Parents complete daily diaries of crying and fussing, and study visits occur at baseline, 6 weeks, and 3 months, with a longer follow-up at 1 year; additional contacts are made by telephone as needed. Primary outcomes are peak crying/fussing time at 6 weeks and occurrence of infantile colic during the first 3 months, while secondary outcomes include stool characteristics, fecal and skin microbiome composition, infant quality of life, and parental stress/satisfaction. Safety and tolerability are monitored throughout the intervention period.
Who should consider this trial
Good fit: Healthy, full-term infants (≥37 weeks' gestation) aged 1–14 days born at the UZ Brussel maternity ward whose guardians can give consent and agree to avoid other probiotic products for the study period are eligible.
Not a fit: Infants with major congenital anomalies, suspected chronic disorders, immunodeficiency, current infection at pre-examination, those born before 37 weeks, or whose guardians cannot comply with language or probiotic-restriction requirements are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the supplement could reduce crying and colic in some newborns and improve stool and skin microbial profiles, potentially easing parental stress.
How similar studies have performed: Previous systematic reviews and meta-analyses have shown that certain L. reuteri strains can significantly reduce infant crying and fussing, but this specific two-strain combination is a novel formulation being tested for preventive use from the first days of life.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jette, Brussels Capital
- Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium (Recruiting)
Study contacts
- Principal investigator: Koen Huysentruyt, Pediatric Gastroenterologist — Universitair Ziekenhuis Brussel
- Study coordinator: Koen Huysentruyt, Pediatric Gastroenterologist
- Email: koen.huysentruyt@uzbrussel.be
- Phone: +32 02/476.37.17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.