Overlap FGIDs and Genetic Polymorphism

NCT ID: NCT04712617

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Functional Gastrointestinal Disorders Overlap Syndromes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FGIDs

Patient who were diagnosed with NERD/RH, FD, IBS and their overlaps (NERD/RH-FD, NERD/RH-IBS, FD-IBS, NERD/RH-FD-IBS)

No interventions assigned to this group

Healthy controls

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

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayoung Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Other Identifiers

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B-2006-616-128

Identifier Type: -

Identifier Source: org_study_id

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