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Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.

Study acronym: ProtectPrevent
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Jan 31, 2026
    • Study description shortened, about 8 words
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07347743
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: BioGaia AB
Conditions
(from sponsor)		 Colic, Healthy Infants, Eczema Atopic Dermatitis
Related terms Colic, Crying
Enrollment 768 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov