Overlap FGIDs and Genetic Polymorphism

Completed

• Conditions: Functional Gastrointestinal Disorders; Overlap Syndromes

• Registration Number: NCT04712617
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

1. 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.

2. To identify the differences in clinical features according to sex and gender.

3. To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-01
• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients	per 16 years