Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 30 participants (planned 25)
    • Primary completion date changed from estimate of Jun 1, 2027 to Jul 22, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised
  2. Primary completion date: Jun 30, 2026 to Jun 1, 2027v4
  3. Start date changed from estimate of Mar 25, 2025 to May 21, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 1, 2025 to Mar 25, 2025
    • Site details revised
    v2
  5. 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.
The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut microbial hydrogen sulfide (H₂S) production. The core design is a single-site, 2-period, crossover feeding study with 6-day diet periods and an approximately 11-day washout period. Participants are fed each of two isocaloric diets designed to contrast gut microbial H₂S production (i.e., a high cysteine vs. low cysteine diet), in a random order.
Trial Details
NCT Number NCT06802276
Lead Sponsor University of Colorado, Denver
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Maryland, College Park
Conditions
(from sponsor)		 Hydrogen Sulfide, Gastrointestinal Microbiome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov