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Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years

Study acronym: PrimiBiota
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Trial completed · Study completion date changed from estimate of Dec 30, 2025 to Jun 1, 2026 · Eligibility criteria expanded, about 9 words · 2 more Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Dec 30, 2025 to Jun 1, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 11 words
  2. Completion date: Dec 30, 2024 to Dec 30, 2025v13
  3. Completion date: Jun 30, 2024 to Dec 30, 2024v12
  4. Completion date: Dec 31, 2023 to Jun 30, 2024v11
  5. Primary completion date changed from estimate of Sep 2022 to Nov 28, 2022 Completion date: Sep 2022 to Dec 31, 2023v10 Show 1 more changeShow less
    • Completion date: Sep 2022 to Dec 31, 2023
Show 8 earlier versionsHide 8 earlier versions
  1. 2 versions Re-verified since Jan 26, 2021, no change to tracked fieldsv8-v9
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 3 of 3 sitesv7 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  3. Primary and study completion dates: Sep 2021 to Sep 2022v6
  4. Primary and study completion dates: Sep 2020 to Sep 2021 Eligibility criteria expanded, about 50 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2016 to May 12, 2017 · Enrollment target: 100 to 130 · Site details revised at 3 of 3 sitesv4 Show 3 more changesShow less
    • Start date: Sep 2016 to May 12, 2017
    • Enrollment target: 100 to 130
    • Site details revised at 3 of 3 sites
  6. Re-verified, no change to tracked fieldsv3
  7. Study title shortened, about 8 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.
Trial Details
NCT Number NCT02738411
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Infant, Premature
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov