Effect of Spore-forming Probiotics in Functional Dyspepsia Patients: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of clinical responders (first 8 weeks) in sporebiotics vs. placebo
研究概览
简要总结
Single-site prospective interventional study aiming to demonstrate the effect of spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in FD patients with and without acid suppression, compared to placebo.
详细描述
Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) with open-label extension phase (8 weeks):
- cohort 1FD (on-PPI): study procedures at inclusion (1) and after 8 weeks on-PPI+ sporebiotics or placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)
- cohort 2FD (off-PPI): study procedures at inclusion (1) and after 8 weeks of sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label)
Clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1 month (week 4 and 12).
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)
盲法说明
participants, care providers, investigators and outcomes assessor are blinded during the randomized placebo-controlled phase (8 weeks) but not during the open-label extension phase (8 weeks)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years with FD diagnosis (Rome IV criteria)
- •Male or female (not pregnant or lactating and using contraception or postmenopausal)
- •Normal bowel habits (defecation once every 3 days up to 3 times a day)
- •Witnessed written informed consent
- •Access to home freezer (-18 to -20°C)
- •Capable to understand and comply with the study requirements
排除标准
- •Any 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)
- •Use of immunosuppressants or antibiotics <3 months
- •History of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy)
- •Personal history of diabetes mellitus type 1, celiac disease or inflammatory bowel disease
- •Diabetes mellitus type 2 (including therapy)
- •Active malignancy (including therapy)
- •Known HIV, HBV or HCV infection (including therapy)
- •Significant alcohol use (>10 units/weeks)
结局指标
主要结局
Proportion of clinical responders (first 8 weeks) in sporebiotics vs. placebo
时间窗: 8 weeks
The Leuven Postprandial Distress Scale (LPDS) is a daily diary assessing the severity of 11 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.7 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing averaged pre-treatment scores with the average score during the last week on treatment with sporebiotics vs. placebo. Only subjects with baseline score \>1 (mild) will be included in the intention-to-treat and per-protocol analysis.
次要结局
- Proportion of minimal clinical responders (first 8 weeks) in sporebiotics vs. placebo(8 weeks)
- Change in weekly individual symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in monthly PAGI-QOL score from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in high-sensitivity C-reactive protein (hs-CRP) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in peripheral blood mononuclear cells on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in plasma cytokines on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in weekly PDS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in weekly EPS symptoms from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Proportion of (minimal) clinical responders (3 of the last 4 weeks of treatment) in sporebiotics vs. placebo(8 weeks)
- Weekly (minimal) clinical responder rates in sporebiotics vs. placebo(8 weeks)
- Change in monthly PAGI-SYM score from baseline (first 8 weeks) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in lipopolysaccharide-binding protein (LBP) on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Change in stool microbiota on sporebiotics vs. placebo and changes within-groups(8 weeks)
- Safety of sporebiotics vs. placebo(16 weeks)