Preventing excessive crying and colic in newborns with a probiotic supplement of two L. reuteri strains

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.