Status:
NOT_YET_RECRUITING
FMT for Insomnia Disorder (FMT-SLEEP)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Chronic Insomnia Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Insomnia disorder is characterized by difficulty initiating or maintaining sleep, or early morning awakening accompanied by symptoms such as irritability or fatigue during wakefulness. It is one of th...
Detailed Description
Insomnia disorder is characterized by difficulty initiating or maintaining sleep, or early morning awakening accompanied by daytime symptoms such as irritability or fatigue. It is one of the most prev...
Eligibility Criteria
Inclusion
- 1\. Individuals aged 18 and above
- 2\. Subjects who were diagnosed with chronic insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and with moderate or above insomnia disorder defined as ISI \> 14
Exclusion
- 1\. Having an additional sleep disorder, such as restless legs syndrome, or circadian rhythm sleep disorder, that can significantly disrupt the sleep cycle as ascertained by Diagnostic Interview for Sleep Patterns and Disorders (DISP)
- 2\. Requiring immediate psychiatric care (e.g., imminently suicidal subjects) or have attempted suicide in the past 6 months
- 3\. Change of treatment or therapy for insomnia within 4 weeks
- 4\. Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
- 5\. Confirmed active malignancy
- 6\. Had abdominal surgery
- 7\. Contraindications to GI endoscopy
- 8\. On shift work
- 9\. Taking antibiotics, probiotic or prebiotic preparations within 4 weeks
- 10\. Known pregnancy
- 11\. Mental retardation or inability to provide informed consent
- 12\. Are participating in other interventional studies
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06606938
Start Date
November 1 2024
End Date
April 30 2027
Last Update
September 23 2024
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong