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:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT06628804
Eligibility Criteria:
Inclusion Criteria:
* Rome IV-based functional dyspepsia-
Exclusion Criteria:
* Patients with gastrointestinal symptoms requiring immediate drug treatment.
* Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.
* Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.
* Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.
* Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year.
* Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy.
* Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg).
* Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL).
* Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution.
* Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution.
* Alcohol abusers.
* Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders).
* Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period.
* Individuals with allergies to any components of the study foods.
* Individuals who participated in or plan to participate in another drug clinical trial within the last month.
* Individuals deemed unsuitable for the study by the investigator for other reasons.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT06628804
Study Brief:
Protocol Section:
NCT06628804