Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT06326918
Eligibility Criteria:
Inclusion Criteria:
1. Functional dyspepsia group 1.1 Patients who are 18 years old or more and exhibit at least one of the following four symptoms for the last 3 months, with symptom onset occurring at least 6 months prior to diagnosis.
1.1.1 Postprandial distress syndrome (symptoms occurring at least 3 days per week), including:
* Postprandial fullness and/or
* Early satiation 1.1.2 Epigastric pain syndrome (symptoms occurring at least 1 day per week), including:
* Epigastric pain and/or
* Epigastric burning 1.2 Participants undergo esophago-gastro duodenoscopy (EGD) to confirm the absence of any structural abnormalities.
2. Control group
* Patients with no or minimal upper GI symptoms (not match the criteria of FD) and current EGD appear normal or insignificant gastritis
* Age- and sex-matched to the functional dyspepsia (FD) patient group.
Exclusion Criteria:
* Participants with known organic causes of dyspepsia, including peptic ulcers, gastrointestinal malignancies, or inflammatory bowel disease
* Participants with a history of gastric or hepatobiliary surgery
* Participants who have taken antibiotics and probiotics (as supplements) within 4 weeks before the study
* Participants with significant systemic illnesses, including severe liver or kidney disease, immunodeficiency disorders, or autoimmune diseases
* Pregnant or breastfeeding participants
* Participants who are unable or unwilling to undergo endoscopic procedures for duodenal mucosa collection
* Participants who have taken PPI within 2 weeks before the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06326918
Study Brief:
Protocol Section:
NCT06326918