Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Sponsor
Nimble Science Ltd.
Study ID
NCT05633706
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • fluid biopsy capsule — DEVICE
    Collection of a fluid biopsy from the small intestine via ingestible capsule

Study Details

The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.

Key Dates

First listed
Dec 1, 2022
Start date
Jan 9, 2023
Status verified
Apr 2025
Primary completion
Jun 6, 2025
Completion
Jun 6, 2025

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Healthy
    Not belonging to the other cohorts as described below.
  • Arm: Irritable Bowel Syndrome
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
  • Arm: Crohns Disease
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
  • Arm: Ulcerative Colitis
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
  • Arm: Celiac Disease
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
  • Arm: Functional Dyspepsia
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
  • Arm: Type 2 Diabetes
    As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.

Primary Outcome Measure

Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping. [ Time Frame: baseline, pre-procedure ]

Central Contacts

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