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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797207
• Other study ID #: 2022-12-08
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Istanbul Medipol University Hospital
• Contact: Varol TUNALI, Dr.
• Phone: 00905556303231
• Email: varoltunali[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Microbiota

Intervention

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

Locations

Country	Name	City	State
Turkey	Medipol University Esenler Hospital	Istanbul	Other (Non U.s.)

Sponsors (6)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital	Bozyaka Training and Research Hospital, Bursa City Hospital, Izmir Metropolitan Municipality Esrefpasa Hospital, SB Istanbul Education and Research Hospital, Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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