Overlap FGIDs and Genetic Polymorphism

January 14, 2021 updated by: Nayoung Kim, Seoul National University Bundang Hospital

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

  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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Nayoung Kim, Professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2004

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2006-616-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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