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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT07196735
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18 - 75 years
* Fulfilling the ROME IV criteria for functional dyspepsia (for FD patients)
* FD unexplained by upper GI endoscopy during the past 12 months (mild gastritis allowed) (for FD patients).
Exclusion Criteria:
* Clinical suspicion of an organic disorder different from FD (patients can be included when this disorder had been excluded);
* Abnormality on upper GI endoscopy other than mild gastritis (for FD patients).
* Known reflux oesophagitis Los Angeles grade C or D, known Barrett oesophagus, peptic stricture.
* H pylori infection, unless treated at least 6 months before;
* Known inflammatory bowel disorder;
* Known major intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 12 weeks;
* Dietary supplements unless taken at a stable dose for more than 12 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);
* Treatment with PPI's during the past 8 weeks
* Pregnancy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07196735
Study Brief:
Protocol Section:
NCT07196735