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NOT YET RECRUITING

NCT07198243

PHASE4

The Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-09-30

Completion Date

2028-12-01

Last Updated

2025-09-30

Healthy Volunteers

Conditions

Functional Dyspepsia

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 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

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.

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

Locations (1)

University Hospitals Leuven / UZLeuven

Leuven, Belgium