Using fecal microbiota transplantation to treat chronic insomnia
The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder
This study is testing whether taking fecal microbiota capsules can help people with chronic insomnia sleep better compared to a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University Sixth Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05917379 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of fecal microbiota transplantation (FMT) delivered via oral capsules in patients diagnosed with chronic insomnia disorder. Participants will be divided into two groups: one receiving the FMT capsules and the other receiving placebo capsules that look identical but contain starch. The study aims to compare the sleep quality of both groups using standardized measures such as the Pittsburgh Sleep Quality Index (PSQI) and polysomnography (PSG). The trial is designed to assess both the efficacy and safety of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with a diagnosis of chronic insomnia disorder as per DSM-5 criteria.
Not a fit: Patients with significant gastrointestinal disorders or those undergoing immunosuppressive therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from chronic insomnia.
How similar studies have performed: While the use of fecal microbiota transplantation is gaining interest, this specific approach for treating chronic insomnia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Peking University Six Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lin Lu, PHD
- Email: gaoteng@bjmu.edu.cn
- Phone: 18911101882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.