The Efficacy and Safty of FMT in Patients With CID

The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder

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.

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