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| Name | Class |
|---|---|
| Izmir Metropolitan Municipality Esrefpasa Hospital | OTHER |
| Bozyaka Training and Research Hospital | OTHER |
| Tepecik Training and Research Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy | Experimental | Fecal samples will be obtained from patients who are enrolled for colonoscopy procedure for the suspicion of inflammatory bowel disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-assisted Fecal Microbiome Testing | Diagnostic Test | Next-generation sequencing of fecal samples and artificial intelligence analysis of test results |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varol TUNALI, Dr. | Contact | 00905556303231 | varoltunali@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Varol TUNALI, Dr. | Celal Bayar University Faculty of Medicine Parasitology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol University Esenler Hospital | Recruiting | Istanbul | Other (Non U.s.) | 34230 | Turkey (Türkiye) |
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| SB Istanbul Education and Research Hospital |
| OTHER |
| Bursa City Hospital | OTHER_GOV |
Fecal samples will be obtained from patients who are enrolled for colonoscopy for the clinical suspicion of inflammatory bowel disease
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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
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| Colonoscopy | Procedure | Colonoscopy procedure |
|
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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