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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT07187492
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
* Aged 18 to 80 years, regardless of gender.
* Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.
Exclusion Criteria:
* Use of probiotics or antibiotics within one month prior to the trial.
* Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.
* Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.
* Participation in any other clinical trial within one month prior to the study.
* Positive test for Helicobacter pylori (Hp) infection.
* Long-term use of traditional Chinese herbal medicine.
* Pregnancy or lactation.
* History of drug abuse.
* Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.
* History of major surgery or diagnosis of diabetes mellitus.
* Refusal to provide written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07187492
Study Brief:
Protocol Section:
NCT07187492