Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Trial sites expanded: 2 → 8 locations Show 5 more changesShow less
    • Final enrollment: 267 participants (planned 300)
    • Interventions modified
    • Eligibility criteria expanded, about 171 words
    • Study description expanded, about 189 words
    • Collaborators: 1 to 9
  2. Primary completion date: Dec 2025 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2025 to Dec 2027
    • Site details revised at 2 of 2 sites
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: Dec 2023 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2025
    v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Dec 2021 to Dec 2023v8
  2. Study sites: 1 to 2v7
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Feb 2021 to Dec 2021
    • Study sites: 0 to 1
    • Study completion date: Nov 2021 to Dec 2024
    • Start date changed from estimate of Nov 20, 2020 to Nov 29, 2020
  4. Start date: Jul 1, 2020 to Nov 20, 2020
    • Primary completion date: Oct 2020 to Feb 2021
    • Study completion date: Oct 2020 to Nov 2021
    v5
  5. Start date: May 1, 2020 to Jul 1, 2020v4
  6. Start date: Mar 2020 to May 1, 2020v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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 is a three-arm, non-interventional observational study designed to investigate the relationship between Crohn's disease (CD), the microbiome, and diet in children.
Trial Details
NCT Number NCT04283864
Lead Sponsor Weizmann Institute of Science
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Schneider Children's Medical Center, Israel, Federico II University, Hospital Sant Joan de Deu, Children's Hospital Zagreb, Stockholm South General Hospital, Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC), University of Alberta, Tel-Aviv Sourasky Medical Center
Conditions
(from sponsor)		 Crohn Disease
Related terms Crohn Disease
Enrollment 267 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov