Functional Gastrointestinal DisordersNCT04712617
Overlap FGIDs and Genetic Polymorphism
An observational study of Functional Gastrointestinal Disorders and Overlap Syndromes, run by Seoul National University Bundang Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders, Overlap Syndromes
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Sex and Gender Difference in Overlap Syndrome of Functional Gastrointestinal Disorder and the Effect of Genetic Polymorphism in South Korea
- 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.
- To identify the differences in clinical features according to sex and gender.
- To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.
- Keywords
- functional gastrointestinal disorder, overlap syndromes, functional dyspepsia, irritable bowel syndrome, non-erosive reflux disease, reflux hypersensitivity
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity score (5 Likert scale, from 0 to 4)
FGID symptom severity score score by K-BDQ
Measured: per 16 years
Hospital anxiety and depression scale (HADS)
by HADS questionnaire
Measured: per 16 years
Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene
Measured: per 16 years
Secondary outcomes (1)
Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients
Measured: per 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startJul 2004
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712617
- Sponsor's protocol ID
- B-2006-616-128
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex and Gender Difference in Overlap Syndrome of Functional Gastrointestinal Disorder and the Effect of Genetic Polymorphism in South Korea
- ClinicalTrials.gov ID
- NCT04712617
- Acronym / sponsor ID
- B-2006-616-128
- Keywords
- functional gastrointestinal disorder, overlap syndromes, functional dyspepsia, irritable bowel syndrome, non-erosive reflux disease, reflux hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2004 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To identify the differences in clinical features according to sex and gender.
- To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom severity score (5 Likert scale, from 0 to 4)
Time frame: per 16 years
FGID symptom severity score score by K-BDQ
Hospital anxiety and depression scale (HADS)
Time frame: per 16 years
by HADS questionnaire
Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene
Time frame: per 16 years
1 secondary outcome
Prevalence of overlap syndromes among FGIDs(NERD or RH, FD, and IBS) patients
Time frame: per 16 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayoung Kim, Professor principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Overlap Syndromes, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity score (5 Likert scale, from 0 to 4) (time frame: per 16 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.