Overlap FGIDs and Genetic Polymorphism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04712617

Enrollment

800

Registered

2021-01-15

Start date

2004-07-31

Completion date

2020-08-31

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders, Overlap Syndromes

Keywords

functional gastrointestinal disorder, overlap syndromes, functional dyspepsia, irritable bowel syndrome, non-erosive reflux disease, reflux hypersensitivity

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results