Insomnia Chronic, Fecal Microbiota Transplantation, Sleep Disorder, Depression, Anxiety, Cognitive Impairment
Conditions
Brief summary
This clinical trial aims to learn about the efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question\[s\] it aims to answer is: • 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, they will be given the same appearance capsules containing starch. Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.
Interventions
BIOLOGICALfecal microbiota
FMT utilizes stool from a healthy donor and puts them into capsules after processing
OTHERPlacebo
Starch into the same outlook capsule with fecal microbiota
DIETARY_SUPPLEMENTsynbiotics
Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)
Sponsors
Peking University Sixth Hospital
Hefei Fourth People's Hospital/Anhui Mental Health Center
The Second Hospital of Anhui Medical University
First Affiliated Hospital of Chongqing Medical University
Henan Provincial Mental Hospital/The Second Affiliated Hospital of Xinxiang Medical University
The First Affiliated Hospital of Shanxi Medical University
Shandong First Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed CID by DSM-5 2. 18-60 years old24 3. Body Mass Index (BMI) within the range of 18-24 kg/m² 4. No other pharmacologic treatment in the last month or at the stable maintenance stage (stable dose for more than two months)
Exclusion criteria
1. Currently pregnant, planning pregnancy shortly, or breastfeeding 2. Undergoing or recently received immunosuppressive therapy, or severe immunosuppression (neutrophil count \<1500 cells/mm³, lymphocyte count \<500 cells/mm³) 3. Diagnosis of one or more specific gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, gastrointestinal tumors, pseudomembranous enteritis, gastrointestinal bleeding, enterocutaneous fistula, etc.) 4. Diseases with significant correlations to gut microbiota include Type 2 Diabetes, thyroid disorders, migraines, and autoimmune diseases 5. Ex-/intraintestinal organ infection 6. Abnormal liver or kidney function 7. Faecal occult blood test (+) 8. Suffering from chronic pain, restless leg syndrome, obstructive sleep apnea, or thyroid disorders. 9. Central nervous system disorders (e.g., epilepsy, Parkinson's disease, history of traumatic brain injury, cerebrovascular diseases, etc.) 10. Current smokers or alcohol drinkers 11. History of food or antibiotic allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index，PSQI | baseline and 1-, 2-, 3-, 6- months post FMT | The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessments and 5 self-assessment items, of which the 19th self-assessment item and 5 self-assessment items do not participate in the scoring. The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality |
| Insomnia Severity Index，ISI | baseline and 1-, 2-, 3-, 6- months post FMT | ISI is a commonly used insomnia severity scale used to assess the extent and impact of individual insomnia in the past two weeks. The ISI consists of seven items, and individuals need to choose the answer best suitable for their condition on each item, and then aggregate the scores of all items to get the total score. The total score ranged from 0 to 28, with higher scores indicating higher insomnia severity. Each item has four answer options, used to describe the frequency of insomnia, severity and effects on the individual. |
| Bray-Curtis dissimilarity | baseline and 1-month post FMT | Bray-Curtis dissimilarity is a beta diversity metric used to quantify differences in microbial community composition between two time points. A higher dissimilarity score indicates greater divergence in taxonomic profiles. This outcome measures the change in gut microbiota structure from baseline to 1-month after fecal microbiota transplantation (FMT), serving as an index of engraftment and microbial shift |
| Sleep onset latency (SL) | baseline and 1 month post FMT | Based on polysomnography (mins) |
| Self-Rating Anxiety Scale (SAS) | baseline and 1-, 2-, 3-, 6- months post FMT | Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2 points), quite a large amount of time (3 points), most or all of the time (4 points). An initial assessment of individual anxiety was possible by calculating the total score. |
| Self-Rating Depression Scale (SDS) | baseline and 1-, 2-, 3-, 6-months post FMT | It usually contains 20 topics and is widely used in research and clinical practice. Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2), quite a large amount of time (3), most or all of the time (4). The total raw score ranges from 20 to 80, and is typically converted to a standard score by multiplying by 1.25 (range: 25 to 100), with higher scores indicating greater severity of depression. |
| Gastrointestinal Symptom Rating Scale，GSRS | baseline and 1-, 2-, 3-, 6-months post FMT | The GSRS includes 15 questions about gastrointestinal symptoms covering a range of symptoms including abdominal pain, flatulence, nausea, vomiting, loss of appetite, etc.The score rang from 16-112, the less the better. |
| Arousal index (ArI) | baseline and 1-month post FMT | Based on polysomnography (events/h) |
| Non-rapid eye movement sleep duration(NREM) | baseline and 1-month post FMT | Based on polysomnography (mins) |
| Rapid eye movement sleep duration(REM) | baseline and 1-month post FMT | Based on polysomnography (mins) |
| Observed OTUs | baseline and 1-month post FMT | Observed OTUs (Operational Taxonomic Units) represent the count of unique taxa identified in a sample, reflecting species richness. This outcome measures the number of observed OTUs in fecal samples at baseline and 1-month post-FMT, indicating changes in microbial richness following intervention. |
| Shannon Diversity Index | baseline and 1-month post FMT | The Shannon index is a commonly used α-diversity metric that accounts for both richness and evenness in microbial communities. Higher values reflect greater diversity. This outcome evaluates within-sample microbial diversity before and after FMT. |
| Simpson Diversity Index | baseline and 1-month post FMT | The Simpson index measures the probability that two randomly selected individuals in a sample belong to the same species. It is sensitive to dominant taxa. This outcome assesses within-sample microbial diversity changes induced by FMT. |
| Chao1 Richness Estimator | baseline and 1-month post FMT | The Chao1 index estimates microbial species richness by accounting for the number of rare taxa (singletons and doubletons). It provides a more robust estimate of total richness compared to observed OTUs. This outcome evaluates the estimated richness change after FMT. |
Countries
China
Contacts
STUDY_DIRECTORLu
Peking University six hospital
Outcome results
None listed