NCT07198243

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

Prospective Randomized Controlled Proof-of-concept Trial to Investigate the Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: Belgium