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Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic

StatusCompleted
PhaseNot applicable
SponsorBioGaia AB
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Primary completion date changed from estimate of Oct 30, 2025 to Sep 10, 2025
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 18 words
  2. Primary completion date: May 31, 2024 to Oct 30, 2025
    • Study completion date: Aug 31, 2024 to Oct 30, 2025
    v3
  3. Enrollment target: 120 to 102v2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Dec 31, 2023 to May 31, 2024
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Collaborators: 1 to 2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BioGaia AB
8 trials monitored
See 1 trial at risk
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Trial Details
NCT Number NCT05512234
Lead Sponsor BioGaia AB
Collaborators: Atlantia Food Clinical Trials, CTC Clinical Trial Consultants AB
Conditions
(from sponsor)		 Colic, Infantile
Related terms Colic
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov