NCT05797207

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 6, 2023

Last Update Submit

March 21, 2023

Conditions

Inflammatory Bowel DiseasesMicrobiotaColonoscopy

Keywords

MicrobiomeInflammatory bowel diseaseColonoscopyArtificial intelligenceScreening test

Outcome Measures

Primary Outcomes (1)

  • The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting inflammatory bowel disease compared to colonoscopy

    The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting inflammatory bowel disease, as measured by sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC-ROC).

    2 weeks

Study Arms (1)

Colonoscopy

EXPERIMENTAL

Fecal samples will be obtained from patients who are enrolled for colonoscopy procedure for the suspicion of inflammatory bowel disease

Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome TestingProcedure: Colonoscopy

Interventions

Artificial Intelligence-assisted Fecal Microbiome TestingDIAGNOSTIC_TEST

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

Colonoscopy
ColonoscopyPROCEDURE

Colonoscopy procedure

Colonoscopy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • under 18 years old Pregnant or planning to become Acute diarrhea cases Have another known diagnosis of gastrointestinal disease ( malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
  • Abdominal surgery other than appendectomy or hysterectomy history
  • Psychiatric comorbidity
  • Chronic disease that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
  • Use of drugs that may affect digestive function (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics) in the 4 weeks before the study
  • Patients taking dietary supplements will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University Esenler Hospital

Istanbul, Other (Non U.s.), 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Varol TUNALI, Dr.

    Celal Bayar University Faculty of Medicine Parasitology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Varol TUNALI, Dr.

CONTACT

00905556303231varoltunali@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The patients will be blinded to the microbiome results for the study period. The gastroenterologists will be blinded to microbiome results. The microbiome researchers will be blinded to colonoscopy results The statisticians will be blinded to both intervention results until the end of patient enrollment
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Fecal samples will be obtained from patients who are enrolled for colonoscopy for the clinical suspicion of inflammatory bowel disease
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 4, 2023

Study Start

April 10, 2023

Primary Completion

February 28, 2024

Study Completion

December 31, 2024

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)