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Recruiting Phase 1 NCT03764748

Washed Microbiota Transplantation for Tourette's Syndrome

Trial Parameters

Condition Tourette Syndrome
Sponsor The Second Hospital of Nanjing Medical University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 6 Years
Max Age 17 Years
Start Date 2024-04-17
Completion 2027-10-31
Interventions
Washed Microbiota Transplantation

Brief Summary

This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).

Eligibility Criteria

Inclusion Criteria: 1. Patients were aged 6 to 17 years (inclusive); 2. Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for TS; 3. Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 at screening and baseline. 4. Underwent WMT. Exclusion Criteria: 1. Complicated with certain brain disease, including tumor,injury,cerebrovascular disease; 2. Complicated with other severe disease, including cancers, organ failure, heart diseases; 3. Stereotypy associated with autism spectrum disorder; 4. With a confirmed diagnosis of psychiatric diseases, such as bipolar disorders; schizophrenia and major depressive disorders; 5. Clinically significant obsessive-compulsive disorder at baseline considered to be the primary cause of impairment at baseline; 6. Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT. 7. Other neurologic disorders other than TS that could influence the evaluation of ti

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