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OpenTrials
Completed

NCT Number: NCT04712617

Overlap FGIDs and Genetic Polymorphism

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.

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Key information

Conditions

Functional Gastrointestinal Disorders Colonic Diseases Colonic Diseases, Functional Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Non-Erosive Reflux Disease Overlap Syndromes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Symptom severity score (5 Likert scale, from 0 to 4)

    Time frame: per 16 years

    FGID symptom severity score score by K-BDQ

  2. Hospital anxiety and depression scale (HADS)

    Time frame: per 16 years

    by HADS questionnaire

  3. Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene

    Time frame: per 16 years

Secondary outcomes

  1. Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients

    Time frame: per 16 years

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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