Prospective Randomized Controlled Proof-of-concept Trial to Investigate the Effects of STW 5-II on Duodenal Mucosa and Symptoms in Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Functional dyspepsia patients taking the matching placebo for 8 weeks.
干预措施: Placebo (Drug)
STW 5-II
Functional dyspepsia patients taking STW 5-II, the active product for the treatment of FD.
干预措施: STW 5-II (Drug)
结局指标
主要结局
Difference in duodenal mucosal eosinophil count between baseline and the end of the treatment (week 8) in both arms
时间窗: 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.
次要结局
- The effect of STW 5-II vs. placebo therapy on clinical symptoms(8 weeks)
- The effect of STW 5-II in other immune cells(8 weeks)
- Changes in Mucosal permeability(8 weeks)