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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521141-24-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Functional dyspepsia patients taking the matching placebo for 8 weeks. |
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| STW 5-II | Experimental | Functional dyspepsia patients taking STW 5-II, the active product for the treatment of FD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STW 5-II | Drug | 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms | For the primary outcome, the number of eosinophils per square mm tissue will be counted as described by Ceulemans M et al. The numbers of cells will be compared at the end of treatment between both study arms. The baseline values and the delta over time will also be compared between both groups. If necessary, the baseline value can be added as co-variate in the statistical analysis. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of STW 5-II vs. placebo therapy on clinical symptoms | The LPDS diary will be analysed using a linear mixed model on data collected up to 8 weeks, including the baseline value as a covariate and including stratum, randomised group, and time (4 weeks and 8 weeks) as fixed factors in the model. The interaction between time and group will also be included to allow for different evolutions over time for the two groups. A random intercept per patient will be included to account for interdependencies within patient. From this model, the mean difference between randomised groups at 8 weeks will be estimated and presented along with its 95% confidence interval. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of STW 5-II vs. placebo therapy on quality of life | The effect of STW 5-II vs. placebo therapy on quality of life using the Patient Assessment of Upper Gastrointestinal. Disorders-Quality Of Life instrument This is a 30 item questionnaire. Each item is scored on a 6-point Likert scale, ranging from 0 (lowest QOL) to 5 (highest QOL), | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Tack, MD, PhD | Contact | +32 16 34 47 75 | jan.tack@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven / UZLeuven | Leuven | 3000 | Belgium |
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| Placebo | Drug | 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. |
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| 8 weeks |
| The effect of STW 5-II in other immune cells | Mast cells counts will be also done and analysed as described by Ceulemans M et al. The numbers of cells will be compared at the end of treatment between both study arms. The baseline values and the delta over time will also be compared between both groups. If necessary, the baseline value can be added as co-variate in the statistical analysis. | 8 weeks |
| Changes in Mucosal permeability | Changes in Mucosal permeability in transmucosal electrical resistance (TEER) and transmucosal flux of a fluorescent molecule in Ussing chambers, and tight junction proteins will be evaluated before and after treatment | 8 weeks |
| The effect of STW 5-II vs. placebo in co-morbidities (depression ) in functional dyspepsia | co-morbidity of depression using the PHQ-9 questionnaire (Patient Health Questionnaire-9) will be evaluated before vs. after treatment. The PHQ-9 (Patient Health Questionnaire-9) is a self-administered questionnaire used to screen for depression and assess its severity. It has ONE UNIT OF MEASURE, which is the total score of a 9 questions. Each of the nine questions is scored on a scale of 0-3, with 0 being "Not at all" and 3 being "Nearly every day". The total score, which can range from 0 to 27, is then interpreted to determine the level of severity of depression. | 8 weeks |
| The effect of STW 5-II vs. placebo in co-morbidities (somatization) in functional dyspepsia | co-morbidity of somatization using the PHQ-15 questionnaire (Patient Health Questionnaire-15) will be evaluated before vs. after treatment. The Patient Health Questionnaire-15 (PHQ-15) assesses the severity of somatic symptoms. It has ONE UNIT OF MEASURE, which is the total score of a 15 questions. It is scored by assigning values of 0, 1, or 2 to each of the 15 items, corresponding to "not bothered at all," "bothered a little," and "bothered a lot," respectively. The total score, ranging from 0 to 30, reflects the overall severity of somatic symptoms. Higher scores indicate greater severity of somatic symptoms | 8 weeks |
| The effect of STW 5-II vs. placebo in co-morbidities (anxiety) in functional dyspepsia | co-morbidity of somatization using the GAD-7 questionnaire (Generalized Anxiety Disorder 7-item scale) will be evaluated before vs. after treatment. The GAD-7 is a questionnaire used to screen for and assess the severity of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating more severe anxiety. A score of 10 or more suggests a possible GAD diagnosis. | 8 weeks |
| Overall treatment efficacy evaluation | The overall treatment efficacy will be evaluated before vs. after the treatment. AI-overzicht The Overall Treatment Effect (OTE) score, used in clinical settings, is a patient-reported outcome that measures the perceived change in symptoms or health-related quality of life (HRQoL) after a treatment. It's a 15-point scale ranging from -7 to +7, where negative scores indicate worsening symptoms, 0 indicates no change, and positive scores indicate improvement. | 8 weeks |
| Overall symptom severity valuation | The overall symptom score (OSS) will be evaluated before vs. after the treatment. The overall symptom score (OSS) score, used in clinical settings, is a patient-reported outcome that measures the perceived change in symptoms. Symptoms are typically rated using a Likert scale, with options ranging from "no symptom" to "very severe". The scores for individual symptoms are then summed to calculate the overall symptom score | 8 weeks |