The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep efficiency
研究概览
简要总结
The goal of this clinical trial is to learn about The safety and efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question[s] it aims to answer are:
- Safety of the FMT oral capsule pathway in the clinical treatment of chronic insomnia
- Effectiveness of the FMT oral capsule route for patients with chronic insomnia Participants in the intervention group will be given FMT by boral capsule pathway, and in the control group will be given the same appearance capsules containing vitamins.
Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.
详细描述
Donors management and FMT oral capsule used here will be prepared according to the "International consensus conference on Stool Banking for fecal microbiota transplantation in clinical practice"
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
- Double (Participant, Investigator)
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
- •Diagnosed CID by DSM-5
- •18-60 years old24
- •Body Mass Index (BMI) within the range of 18-24 kg/m²
- •No other pharmacologic treatment in the last month or at the stable maintenance stage (stable dose for more than two months)
- •Communication barrier-free and willing to cooperate with the relevant scales and assessments
- •Willing to participate voluntarily in the survey and able to provide informed consent by signing the consent form
排除标准
- •Currently pregnant, planning pregnancy shortly, or breastfeeding
- •Undergoing or recently received immunosuppressive therapy, or severe immunosuppression (neutrophil count <1500 cells/mm³, lymphocyte count <500 cells/mm³)
- •Diagnosis of one or more specific gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, gastrointestinal tumors, pseudomembranous enteritis, gastrointestinal bleeding, enterocutaneous fistula, etc.)
- •Diseases with significant correlations to gut microbiota include Type 2 Diabetes, thyroid disorders, migraines, and autoimmune diseases
- •Ex-/intraintestinal organ infection
- •Abnormal liver or kidney function
- •Faecal occult blood test (+)
- •Suffering from chronic pain, restless leg syndrome, obstructive sleep apnea, or thyroid disorders.
- •Central nervous system disorders (e.g., epilepsy, Parkinson's disease, history of traumatic brain injury, cerebrovascular diseases, etc.)
- •Current smokers or alcohol drinkers
- •History of food or antibiotic allergies
研究组 & 干预措施
FMT
Investigators have 2 subgroups here, pure Fecal microbiota transplantation-F: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning; Fecal microbiota transplantation+synbiotics-M: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticus Bifidobacterium longum + inulin) (3g/day) for 45 days from the beginning.
干预措施: fecal microbiota (Biological)
FMT
Investigators have 2 subgroups here, pure Fecal microbiota transplantation-F: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning; Fecal microbiota transplantation+synbiotics-M: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticus Bifidobacterium longum + inulin) (3g/day) for 45 days from the beginning.
干预措施: synbiotics (Dietary Supplement)
Non-FMT
Investigators have 2 subgroups here, synbiotics control-S: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the beginning; Double Placebo-P: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning.
干预措施: Placebo (Other)
Non-FMT
Investigators have 2 subgroups here, synbiotics control-S: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the beginning; Double Placebo-P: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning.
干预措施: synbiotics (Dietary Supplement)
结局指标
主要结局
Sleep efficiency
时间窗: 1 month post FMT
(Total Time Asleep / Total Time in Bed×100%) of CID patients will be objectively ，assessed using PSG at week 4 post-FMT (compared to baseline). Additionally, subjective measures including PSQI and ISI scores will be included
次要结局
- Pittsburgh Sleep Quality Index，PSQI(baseline and 1-, 2-, 3-, 6- months post FMT)
- Insomnia Severity Index，ISI(baseline and 1-, 2-, 3-, 6- months post FMT)
- Bray-Curtis dissimilarity(baseline and 1-month post FMT)
- Sleep onset latency (SL)(baseline and 1 month post FMT)
- Self-Rating Anxiety Scale (SAS)(baseline and 1-, 2-, 3-, 6- months post FMT)
- Self-Rating Depression Scale (SDS)(baseline and 1-, 2-, 3-, 6-months post FMT)
- Gastrointestinal Symptom Rating Scale，GSRS(baseline and 1-, 2-, 3-, 6-months post FMT)
- Arousal index (ArI)(baseline and 1-month post FMT)
- Non-rapid eye movement sleep duration(NREM)(baseline and 1-month post FMT)
- Rapid eye movement sleep duration(REM)(baseline and 1-month post FMT)
- Observed OTUs(baseline and 1-month post FMT)
- Shannon Diversity Index(baseline and 1-month post FMT)
- Simpson Diversity Index(baseline and 1-month post FMT)
- Chao1 Richness Estimator(baseline and 1-month post FMT)
研究者
Gao Teng
Peking University
Peking University Sixth Hospital