The Efficacy and Safty of FMT in Patients With CID

Launched by PEKING UNIVERSITY SIXTH HOSPITAL · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called fecal microbiota transplantation (FMT) to help people with chronic insomnia disorder, which is a long-term sleep problem. The trial will involve two groups of participants. One group will receive FMT in the form of oral capsules, while the other group will receive capsules that look the same but only contain starch. Researchers will compare the sleep quality of both groups to see if the FMT helps improve sleep.

To participate in this trial, individuals should be between 18 and 60 years old, have been diagnosed with chronic insomnia, and have a specific body weight range. However, some people may not be eligible, such as those who are pregnant, have certain gastrointestinal disorders, or have recently been on specific medications. Participants can expect to take the capsules and undergo sleep assessments during the study. This trial is important because it could lead to new treatments for insomnia, especially for those who haven’t found relief with other methods.

Gender

ALL

Eligibility 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