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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Colonoscopy; Microbiota
• Intervention / Treatment: Diagnostic test: Artificial Intelligence-assisted Fecal Microbiome Testing; Procedure: Colonoscopy

Detailed Description

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a chronic and complex disorder of the gastrointestinal tract that affects millions of people worldwide. IBD is typically diagnosed through a combination of patient history, physical examination, laboratory tests, and imaging studies. However, these methods can be expensive, invasive, and time-consuming, leading to delays in diagnosis and treatment.

Recent research has focused on the potential of using fecal microbiome testing, which analyzes the composition and function of the gut microbiota, as a non-invasive and cost-effective screening tool for IBD. The gut microbiota is a complex ecosystem of microorganisms that plays a critical role in maintaining gut health and immune system function. Changes in the composition or function of the gut microbiota have been associated with the development and progression of IBD.

Artificial intelligence (AI) algorithms can assist in the analysis of fecal microbiome testing data and provide a more accurate and reliable diagnosis of IBD. AI can identify patterns and trends in the complex data generated by microbiome testing that may not be apparent to human analysts, leading to earlier and more accurate diagnosis of IBD.

Furthermore, AI can help identify potential biomarkers of IBD, which could be used for screening and monitoring disease activity. These biomarkers could provide insights into the underlying mechanisms of IBD, leading to the development of more effective therapies and personalized treatment approaches.

Overall, the use of AI-assisted fecal microbiome testing for IBD screening holds significant potential for improving the diagnosis and management of this chronic and debilitating disease.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Varol TUNALI, Dr.; Phone Number: 00905556303231; Email: varoltunali@gmail.com

Study Locations

• Turkey
  • Other (Non U.s.)
    • Istanbul, Other (Non U.s.), Turkey, 34230
      • Recruiting
      • Medipol University Esenler Hospital
      • Contact: Naciye Cigdem Arslan, MD; Phone Number: 05313890975
      • Principal Investigator: Naciye Cigdem Arslan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• being over 18 years of age not to be pregnant To apply with the complaint of chronic diarrhea (4 weeks or more) Not meeting any of the exclusion criteria Signing the voluntary consent form

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy; 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 Testing; Next-generation sequencing of fecal samples and artificial intelligence analysis of test results; Procedure: Colonoscopy; Colonoscopy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Tepecik Training and Research Hospital; Bozyaka Training and Research Hospital; SB Istanbul Education and Research Hospital; Bursa City Hospital; Izmir Metropolitan Municipality Esrefpasa Hospital
• Investigators: Principal Investigator: Varol TUNALI, Dr., Celal Bayar University Faculty of Medicine Parasitology Department

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2023
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Colonoscopy; Artificial intelligence; Inflammatory bowel disease; Screening test
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2022-12-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No