Overlap FGIDs and Genetic Polymorphism (NCT04712617) | Clinical Trial Compass
CompletedNot Applicable
Overlap FGIDs and Genetic Polymorphism
800 participantsStarted 2004-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom severity score (5 Likert scale, from 0 to 4)
Timeframe: per 16 years
2
Hospital anxiety and depression scale (HADS)
Timeframe: per 16 years
3
Genetic polymorphisms of SLC6A4 5-HTTLPR, GNB3, ADRA2, TNFA, IL10 gene