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Prebiotic Galacto-oligosaccharide and Acute GVHD

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Duke University to University of Kansas Medical Center Primary completion date: Jun 1, 2026 to Jun 1, 2027 · Completion date: Feb 1, 2028 to Feb 1, 2029 · Collaborators expanded, about 7 wordsv17 Show 3 more changesShow less
    • Primary completion date: Jun 1, 2026 to Jun 1, 2027
    • Completion date: Feb 1, 2028 to Feb 1, 2029
    • Collaborators expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 1 to 2v16
  3. 4 versions Re-verified since Apr 15, 2024, no change to tracked fieldsv12-v15
  4. Primary completion date: Jun 30, 2025 to Jun 1, 2026 Completion date: Sep 30, 2025 to Feb 1, 2028v11 Show 1 more changeShow less
    • Completion date: Sep 30, 2025 to Feb 1, 2028
  5. Primary completion date: Jun 2026 to Jun 30, 2025 Completion date: Feb 2028 to Sep 30, 2025v10 Show 1 more changeShow less
    • Completion date: Feb 2028 to Sep 30, 2025
Show 8 earlier versionsHide 8 earlier versions
  1. Completion date: Sep 2026 to Feb 2028v9
  2. Site contact updatedv8
  3. Primary completion date: Jun 2025 to Jun 2026 Completion date: Sep 2025 to Sep 2026v7 Show 1 more changeShow less
    • Completion date: Sep 2025 to Sep 2026
  4. Re-verified, no change to tracked fieldsv6
  5. Start date changed from estimate of Dec 2020 to Jan 22, 2021v5
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Nov 2020 to Dec 2020v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Nov 2020 to Dec 2020
  7. Phase: Not applicable to Phase 1/2v3
  8. Start date: Jun 2020 to Nov 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two two parts. In phase 1, the best dose of GOS will be evaluated. In phase 2, using the best dose of GOS, participants will be randomized to receive GOS or a placebo (maltodextrin, a common food additive that is not known to affect the microbiome) so that the effect of GOS can be determined.
Trial Details
NCT Number NCT04373057
Lead Sponsor University of Kansas Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute GVHD
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov