Status:
RECRUITING
Washed Microbiota Transplantation for Tourette's Syndrome
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Collaborating Sponsors:
Nanjing Medical University
Conditions:
Tourette Syndrome
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief Summary
This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).
Detailed Description
Emerging scientific data support the significant role of microbiota in the modulation of the central nervous system. The reconstitution of gut microbiota might be a potential option to treat Tourette'...
Eligibility Criteria
Inclusion
- Patients were aged 6 to 17 years (inclusive);
- Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for TS;
- Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 at screening and baseline.
- Underwent WMT.
Exclusion
- Complicated with certain brain disease, including tumor,injury,cerebrovascular disease;
- Complicated with other severe disease, including cancers, organ failure, heart diseases;
- Stereotypy associated with autism spectrum disorder;
- With a confirmed diagnosis of psychiatric diseases, such as bipolar disorders; schizophrenia and major depressive disorders;
- Clinically significant obsessive-compulsive disorder at baseline considered to be the primary cause of impairment at baseline;
- Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT.
- Other neurologic disorders other than TS that could influence the evaluation of tics.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03764748
Start Date
April 17 2024
End Date
October 31 2027
Last Update
August 19 2024
Active Locations (2)
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1
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
2
SIR RUN RUN hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011