The Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STW 5-II, Placebo.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Controlled Proof-of-concept Trial to Investigate the Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia
Overview
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.
Interventions
- Drug STW 5-II
STW 5-II is an herbal medicinal product for the symptomatic treatment of functional dyspepsia with main symptoms such as epigastric pain, epigastric burning, postprandial fullness and early satiation, but often also loss of appetite, excessive belching and heartburn. STW5-II consists of six herbal extracts: bitter candy tuft, camomile flower, caraway fruit, melissa leaf, peppermint leaf, and licorice root. STW 5-II will be a solution for oral intake, for the treatment of FD, administered as 20 - Drug Placebo
Matching placebo will be a solution for oral intake, administered as 20 droplets in liquids, three times daily during 8 weeks. Recommended time of ingestion is just before or with meals. Patients and study staff are blinded for the intervention.
Primary outcome measures
- Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms [Time frame: 8 weeks]
Secondary outcome measures (3)
- The effect of STW 5-II vs. placebo therapy on clinical symptoms [Time frame: 8 weeks]
- The effect of STW 5-II in other immune cells [Time frame: 8 weeks]
- Changes in Mucosal permeability [Time frame: 8 weeks]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- University Hospitals Leuven / UZLeuven — Leuven
Identifiers
NCT: NCT07198243 · S70188 · 2025-521141-24-00