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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04713969
Eligibility Criteria:
Inclusion Criteria:
* Patients with FD diagnosis as per Rome IV criteria (EPS or PDS).
* Normal investigation including upper GI endoscopy.
* Patients have confirmed duodenal mucosal eosinophilia.
* Patients witnessed written informed consent.
* Patients aged between 18 and 64 years inclusive.
* Male or female (not pregnant or lactating and using contraception or postmenopausal).
* Subjects are capable to understand the study and the questionnaires, and to comply with the study requirements.
Exclusion Criteria:
* Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study.
* Patients with any major psychiatric disorders (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications).
* Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD).
* Patients with personal or family (first-degree relative) of diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, lupus, scleroderma, rheumatic or other systemic auto-immune disease.
* Patients with eosinophilic esophagitis or eosinophilic gastroenteritis.
* Active H. pylori infection (or \<6 months after eradication).
* Allergy or atopy, including therapy.
* Organic gastro-intestinal disease or history of gastrointestinal surgery other than appendectomy or splenectomy.
* Known impaired liver or kidney dysfunction, or coagulation disorders.
* Known HIV, HBV or HCV infection, including therapy.
* Active coronary or peripheral artery disease.
* Use of anti-inflammatory drugs or anti-allergy drugs \<2 weeks before sampling.
* Use of immunosuppressants, antibiotics or acid-suppressive drugs \<3 months before sampling.
* Use of prokinetics \<2 weeks before sampling (unless if ≤3/week).
* Significant alcohol use (\>10 units/week).
* Any use of alcohol or smoking \<2 days before sampling.
* Active malignancy, including therapy.
* Females who are pregnant or lactating.
* Patients not capable to understand or be compliant with the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04713969
Study Brief:
Protocol Section:
NCT04713969