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Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Site contact updatedv8
  2. Primary endpoint(s) modified
    • Site contact updated
    v7
  3. Primary completion date: Dec 31, 2025 to Dec 17, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v6
  4. Phase: Early Phase 1 to Phase 4
    • Interventions: L-Phenylalanine 500 mg Veg Capsule product (Dietary Supplement) to L-Phenylalanine 500 mg Veg Capsule product (Drug)
    v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Primary completion date: Dec 2025 to Dec 31, 2025
    • Study completion date: Dec 2026 to Dec 31, 2026
    • Start date changed from estimate of Aug 2024 to Oct 17, 2024
    • Site details revised
    • Study description expanded, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jul 2024 to Aug 2024v3
  2. Start date: May 2024 to Jul 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.
Trial Details
NCT Number NCT06433310
Lead Sponsor Weill Medical College of Cornell University
Conditions
(from sponsor)		 Gut Microbiome, Gut Health, Dietary Supplement, L-Phenylalanine, Phenylpropionic Acid
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov