Overlap FGIDs and Genetic Polymorphism

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712617
• Other study ID #: B-2006-616-128
• Status: Completed
• Start date: July 2004
• Est. completion date: August 2020

Study information

• Verified date: January 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Overlap Syndromes
• Syndrome
• Undifferentiated Connective Tissue Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity score (5 Likert scale, from 0 to 4)	FGID symptom severity score score by K-BDQ	per 16 years
Primary	Hospital anxiety and depression scale (HADS)	by HADS questionnaire	per 16 years
Primary	Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene		per 16 years
Secondary	Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients		per 16 years