RecruitingPhase 1NCT03764748

Washed Microbiota Transplantation for Tourette's Syndrome

Efficacy and Safety of Washed Microbiota Transplantation for Tourette's Syndrome


Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

30 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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.

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Interventions

DRUGWashed Microbiota Transplantation

The prepared microbiota suspension was infused into the participates' lower gut.


Locations(2)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT03764748


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