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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT04302402
Eligibility Criteria:
Inclusion Criteria:
* FD diagnosis by ROME IV criteria (one or more of bothersome symptoms like postprandial fullness, early satiation, epigastric pain, and epigastric burning. It must include criteria for postprandial distress syndrome and epigastric pain syndrome for the last 3 months with symptom onset at least 6 months before diagnosis and no evidence of structural disease, including upper endoscopy).
* No organic disease on upper gastrointestinal endoscopy and ultrasound.
* Currently, not on any active therapy during the last two months.
* No previous history of Helicobacter pylori eradication.
* No antibiotic therapy within the last month.
* Not received proton pump inhibitors for a minimum of 4 weeks prior to study enrollment.
Exclusion Criteria:
* Presence of alarm symptoms such as GI bleeding, unexplained iron deficiency anemia, unintentional weight loss, palpable abdominal mass, family history of colon or stomach cancer or symptom onset ≥50 years of age and not yet screened for colon cancer, or sudden/acute onset of a new change in bowel habit)
* No proper informed consent.
* Endoscopic treatment for gastroesophageal reflux.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04302402
Study Brief:
Protocol Section:
NCT04302402