Status:
NOT_YET_RECRUITING
The Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 conditio...
Eligibility Criteria
Inclusion
- 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
- Capable to understand and comply with the study requirements
Exclusion
- Inclusion criteria:
- 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
- Capable to understand and comply with the study requirements
- Exclusion criteria:
- Major active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
- Chronic ppi use. No PPI use for at least the prior 4 weeks before entering the trial- History of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy)
- History or presence of diabetes mellitus type 1 \& type 2, coeliac disease or inflammatory bowel disease
- Active malignancy
- Known HIV, HBV or HCV infection
- Significant alcohol use (\>10 units/weeks)
- Females pregnant or lactating
- Hypersensitivity against ingredients of STW 5-II or placebo (see annex)
- Abnormal baseline laboratory blood values
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07198243
Start Date
September 30 2025
End Date
December 1 2028
Last Update
September 30 2025
Active Locations (1)
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1
University Hospitals Leuven / UZLeuven
Leuven, Belgium, 3000