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

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05797207

Collaborator

Izmir Metropolitan Municipality Esrefpasa Hospital (Other), Bozyaka Training and Research Hospital (Other), Tepecik Training and Research Hospital (Other), SB Istanbul Education and Research Hospital (Other), Bursa City Hospital (Other)

300

Enrollment

Location

Arm

20.7

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Microbiota Colonoscopy	Diagnostic Test: Artificial Intelligence-assisted Fecal Microbiome Testing Procedure: Colonoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Apr 10, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The diagnostic accuracy of the AI-assisted fecal microbiome testing in detecting inflammatory bowel disease compared to colonoscopy [2 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.