The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo
研究概览
简要总结
Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group
详细描述
Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) :
cohort 1FD : Receiving 8 weeks of Gastrogenic Microbiota cohort 2FD : Receiving 8 weeks of placebo Clinical outcomes and Tryptophan metabolism, Microbiome parameters will be assessed at the beginning and end of each treatment period (week 0, 8).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
participants, care providers, and investigators are blinded during the randomized placebo-controlled phase (8 weeks)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 and ≤70 years, with symptoms such as upper abdominal pain or burning sensation, postprandial bloating, early satiety, etc., and who meet the diagnostic criteria for functional dyspepsia (FD) according to the Rome IV criteria.
- •Negative result on the C13 urea breath test, and no organic changes observed on gastroscopy.
排除标准
- •Use of acid-suppressing drugs, prokinetic agents, antibiotic or anxiolytics within 4 weeks prior to enrollment.
- •History of abdominal surgery, abdominal or inflammatory bowel disease, diabetes, active psychiatric disorders, or severe diseases of vital organs such as the heart, lungs, liver, or kidneys.
- •Pregnant or breastfeeding participants, or those currently involved in other clinical research studies.
结局指标
主要结局
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo
时间窗: 8 weeks
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo \[Time Frame: 8 weeks\] (using the the Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI-SYM).The PAGI-SYM scale is specifically developed for the assessment of functional upper gastrointestinal diseases and is used to evaluate the severity of symptoms associated with these diseases. The scale comprises 21 symptoms of functional upper gastrointestinal diseases, with each symptom rated on a scale from none to very severe, scored as 0, 1, 2, 3, 4, or 5, respectively. The total score is calculated and used to assess the severity of functional upper gastrointestinal diseases.
次要结局
- Changes in the Clinical Rating Scale for The Gastrointestinal Symptoms Rating Scale (GSRS) scores in the Lactobacillus vs. the placebo.(8 weeks)
- Changes in the Quality of Life scores (PAGI-QOL) in the Lactobacillus vs. the placebo.(8 weeks)
- Changes in the Self-Rating Anxiety Scale (SAS) scores in the Lactobacillus vs. the placebo.(8 weeks)
- Changes in the Self-Rating Depression Scale (SDS) scores in the Lactobacillus vs. the placebo.(8 weeks)
- Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group(8 weeks)
- Differences in serum and urine neurotransmitters before and after treatment in the probiotic group(8 weeks)
- Safety of Lactobacillus vs. placebo(8 weeks)