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Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 6 of 6 changed
See other at-risk trials from St. Jude Children's Research Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Eligibility criteria revised
    v21
  2. Eligibility criteria expanded, about 8 wordsv20
  3. Site contact updatedv19
  4. Primary completion date: Dec 31, 2025 to Dec 31, 2026v18
  5. Start date changed from estimate of Jun 12, 2025 to Jul 7, 2025v17
Show 15 earlier versionsHide 15 earlier versions
  1. Start date: Mar 12, 2025 to Jun 12, 2025v16
  2. Enrollment target: 20 to 10
    • Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date: Mar 12, 2024 to Mar 12, 2025
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v15
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Mar 12, 2024
    • Site details revised
    v14
  4. Start date: Sep 2024 to Oct 2024v13
  5. Start date: Jun 2024 to Sep 2024v12
  6. Start date: Apr 2024 to Jun 2024v11
  7. Re-verified, no change to tracked fieldsv10
  8. Start date: Feb 2024 to Apr 2024v9
  9. Start date: Dec 2023 to Feb 2024v8
  10. Start date: Nov 2023 to Dec 2023v7
  11. Start date: Sep 2023 to Nov 2023v6
  12. Start date: Jul 2023 to Sep 2023v5
  13. Start date: Apr 2023 to Jul 2023v4
  14. Start date: Feb 2023 to Apr 2023v3
  15. Start date: Dec 2022 to Feb 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT). Primary Objective * To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT. * To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction. Secondary Objectives * To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT. * To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.
Trial Details
NCT Number NCT05664113
Lead Sponsor St. Jude Children's Research Hospital
Conditions
(from sponsor)		 Gastro-Intestinal Disorder
Related terms Digestive System Diseases
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov