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Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Inflammatory Bowel Disease

NCT05797207 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-04

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the diagnostic potential of Artificial Intelligence-assisted Fecal Microbiome Testing for the diagnosis of inflammatory bowel disease. The main question it aims to answer is:

• Is Artificial Intelligence-assisted Fecal Microbiome Testing a reliable screening test for inflammatory bowel disease?

Participants will be asked to provide fecal samples to be analyzed with next-generation sequencing techniques.

If there is a comparison group: Researchers will compare the diagnostic performance of AI-assisted Fecal Microbiome Testing with colonoscopy to see the correlation between the results of both interventions.

Conditions

  • Inflammatory Bowel Diseases
  • Microbiota
  • Colonoscopy

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence-assisted Fecal Microbiome Testing

Next-generation sequencing of fecal samples and artificial intelligence analysis of test results

PROCEDURE

Colonoscopy

Colonoscopy procedure

Sponsors & Collaborators

  • Izmir Metropolitan Municipality Esrefpasa Hospital

    collaborator UNKNOWN

  • Bozyaka Training and Research Hospital

    collaborator OTHER

  • Tepecik Training and Research Hospital

    collaborator OTHER

  • SB Istanbul Education and Research Hospital

    collaborator OTHER

  • Bursa City Hospital

    collaborator OTHER_GOV

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • Varol TUNALI, Dr. · Celal Bayar University Faculty of Medicine Parasitology Department

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-02-28
Completion
2024-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797207 on ClinicalTrials.gov