Functional DyspepsiaPhase 4DESTINYNCT07198243
The Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia
A Phase 4 study testing STW 5-II in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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 condition that causes frequent stomach discomfort, especially after eating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- STW 5-II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Sep 2025to 1 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients ≥18 years newly to be treated with an FD/PDS diagnosis (Rome IV clinical criteria).
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- 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
Who cannot join
- 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)
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- Females pregnant or lactating
- Hypersensitivity against ingredients of STW 5-II or placebo (see annex)
- Abnormal baseline laboratory blood values
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
University Hospitals Leuven / UZLeuven
Leuven, 3000
CTC UZLeuven, +32 16 34 19 98, ctc@uzleuven.be
About this study
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
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:
Read more
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.
- Conditions
- Functional Dyspepsia
- Being tested
- STW 5-II, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STW 5-IIDrug
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Functional dyspepsia patients taking the matching placebo for 8 weeks. Receives: Drug: Placebo |
| STW 5-II | Experimental | Functional dyspepsia patients taking STW 5-II, the active product for the treatment of FD. Receives: Drug: STW 5-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198243
- Sponsor's protocol ID
- S70188
- Other IDs
- 2025-521141-24-00, 2025
- Acronym
- DESTINY
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07198243
- Acronym / sponsor ID
- DESTINY / S70188
- Conditions
- Functional Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFunctional dyspepsia patients taking the matching placebo for 8 weeks. |
| STW 5-II | Experimental | Drug: STW 5-IIFunctional dyspepsia patients taking STW 5-II, the active product for the treatment of FD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STW 5-IISTW 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 | Drug | STW 5-II |
| PlaceboMatching 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. | Drug | Placebo |
Primary outcome
Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms
Time frame: 8 weeks
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Tack, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing STW 5-II in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack, MD, PhD (+32 16 34 47 75, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.