Overlap FGIDs and Genetic Polymorphism

Study Overview
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Brief Summary
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To analyze the prevalence of overlap syndromes among NERD or RH, FD, and IBS patients, and to identify and to compare the differences in their characteristics and symptoms, and to determine their risk factors. To identify the differences in clinical features according to sex and gender. To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.

Official Title
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Sex and Gender Difference in Overlap Syndrome of Functional Gastrointestinal Disorder and the Effect of Genetic Polymorphism in South Korea

Conditions
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Functional Gastrointestinal Disorders, Overlap Syndromes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FGID group No organic diseases in routine laboratory tests, abdominal imaging, esophagogastroscopy, and colonoscopy NERD or reflux hypersensitivity (RH): typical heartburn occurring at least once a week without visible esophageal mucosal break detected by endoscopy FD or IBS: based on the Rome III criteria Control group - Subjects who underwent GI evaluations as part of health check-up or for other problems, such as mild abdominal discomfort or pain for a relatively short period of time, but had no organic problems during GI endoscopy Exclusion Criteria: history of GI surgery except appendectomy inflammatory bowel disease any malignancy, or systemic diseases requiring chronic medication except for hypertension and diabetes mellitus pregnant or lactating women hepatic, biliary, or psychiatric disorders requiring medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FGIDs<br>Patient who were diagnosed with NERD/RH, FD, IBS and their overlaps (NERD/RH-FD, NERD/RH-IBS, FD-IBS, NERD/RH-FD-IBS) | |
| Healthy controls<br>Subjects who underwent GI evaluations as part of health check-up or for other problems, such as mild abdominal discomfort or pain for a relatively short period of time, but had no organic problems during GI endoscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity score (5 Likert scale, from 0 to 4) | FGID symptom severity score score by K-BDQ | per 16 years | 
| Hospital anxiety and depression scale (HADS) | by HADS questionnaire | per 16 years | 
| Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene |  | per 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients |  | per 16 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional gastrointestinal disorder, overlap syndromes, functional dyspepsia, irritable bowel syndrome, non-erosive reflux disease, reflux hypersensitivity