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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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.

Первичные конечные точки

• Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms [Срок оценки: 8 weeks]

Вторичные конечные точки (3)

• The effect of STW 5-II vs. placebo therapy on clinical symptoms [Срок оценки: 8 weeks]
• The effect of STW 5-II in other immune cells [Срок оценки: 8 weeks]
• Changes in Mucosal permeability [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospitals Leuven / UZLeuven — Leuven

Идентификаторы

NCT: NCT07198243 · S70188 · 2025-521141-24-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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