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

NCT07347743 NA RECRUITING

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.

Details

Lead sponsor	Universitair Ziekenhuis Brussel
Phase	NA
Status	RECRUITING
Enrolment	768
Start date	2026-01-31
Completion	2028-12

Conditions

• Colic
• Healthy Infants
• Eczema Atopic Dermatitis

Interventions

• Two probiotic Limosilactobacillus reuteri strains
• Placebo

Primary outcomes

• Peak measured crying time — 6 weeks
  Peak measured crying time at 6 (±1) weeks according to the prospectively kept baby day diary
• The occurrence of infant colic at any time in the first 3 months of life. — 3 months
  The criteria for infant colic are: * Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers. Fussing refers to intermittent distressed vocalization and refers to behavior that is not quite crying but not awake and content either. * Caregiver reports infant has cried or fussed for 3 or more hours/day during 3 or more days in a given week. * Total 24-hour crying plus fussing in the selected group of infants is confirmed to be 3 hours or more when measured by at least one, prospectively kept, 24-hour behavior diary.

Countries

Belgium