Washed Microbiota Transplantation for Tourette's Syndrome (WMT)

Nanjing Medical University

Status and phase: Enrolling; Phase 1

Conditions: Tourette Syndrome

Treatments: Drug: Washed Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03764748

WMT-TS

Details and patient eligibility

About

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

Full 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's syndrome (TS). FMT has been reported to be a highly effective therapy to restore the gut microbiota dysbiosis by transferring gut microbiota from healthy donors to patients. The newly improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the FMT-standardization study group. FMT has shown treatment potential in several gut-brain axis-related disorders, such as amyotrophic lateral sclerosis and Parkinson's disease, promoting us to investigate its treatment potential for Tourette's syndrome. In this study, investigators aimed to evaluate the efficacy of WMT for Tourette's syndrome and its comorbidities using specialized questionnaires for Tourette's syndrome and investigate the underlying mechanism.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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 tics.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Washed microbiota transplantation

Experimental group

Description:

WMT

Treatment:

Drug: Washed Microbiota Transplantation