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Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants

StatusNot Yet Recruiting
PhasePhase 1
Started
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Record status
This record was last updated August 11, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Start date: Aug 2025 to Sep 2025v5
  2. Notable Primary and study completion dates: Dec 2025 to Aug 2026v4 Show 6 more changesShow less
    • Start date: May 2025 to Aug 2025
    • Secondary endpoints: 3 to 6
    • Study description expanded, about 109 words
    • Site contact updated
    • Collaborator revised
    • Study title expanded, about 5 words
  3. Notable Start date: Feb 2025 to May 2025
    • Primary and study completion dates: Oct 2025 to Dec 2025
    • Site contact updated
    • Collaborators expanded, about 3 words
    v3
  4. Minor Collaborators shortened, about 2 wordsv2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .
Trial Details
NCT Number NCT06704022
Lead Sponsor Nimble Science Ltd.
Collaborators: Alberta Obesity Centre
Conditions
(from sponsor)
Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov