The goal of this clinical trial is to find out whether a herbal medicine called STW 5-II can help improve gut health and symptoms in adults recently diagnosed with functional dyspepsia (FD)-a condition that causes frequent stomach discomfort, especially after eating.
The main questions it aims to answer are:
Can STW 5-II reduce certain immune cells (eosinophils) in the gut lining? Can it improve symptoms like severe postprandial fullness, bloating, epigastric pain, and improve quality of life?
Researchers will compare STW 5-II to a placebo to see if it helps reduce gut inflammation and ease symptoms.
Participants will:
Take either STW 5-II or a placebo for 8 weeks Provide small samples of gut tissue (via endoscopy) Answer questions about their symptoms and daily life An optional 4-week treatment with STW 5-II will follow for all participants.
Patients ≥18 years newly to be treated with an FD/PDS diagnosis (Rome IV clinical criteria).
Newly to be treated patients are defined as patients currently not on any ongoing treatment for FD (including OTC medication) for the last 2 weeks. Medications such as PPI or others that may affect GI function and symptom should be stopped prior the trial (min 4 weeks). See list of forbidden medication.
Male or female using contraception or postmenopausal
Witnessed written informed consent
Patients ≥18 years newly to be treated with an FD/PDS diagnosis (Rome IV clinical criteria).
Newly to be treated patients are defined as patients currently not on any ongoing treatment for FD (including OTC medication) for the last 2 weeks. Medications such as PPI or others that may affect GI function and symptom should be stopped prior the trial (min 4 weeks). See list of forbidden medication.
Male or female using contraception or postmenopausal
Witnessed written informed consent