Washed Microbiota Transplantation for Tourette's Syndrome

Last updated: August 15, 2024
Sponsor: The Second Hospital of Nanjing Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

Autism

Tic Disorders

Treatment

Washed Microbiota Transplantation

Clinical Study ID

NCT03764748
WMT-TS
  • Ages 6-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients were aged 6 to 17 years (inclusive);

  2. Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Editioncriteria for TS;

  3. Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 atscreening and baseline.

  4. Underwent WMT.

Exclusion

Exclusion Criteria:

  1. Complicated with certain brain disease, including tumor,injury,cerebrovasculardisease;

  2. Complicated with other severe disease, including cancers, organ failure, heartdiseases;

  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 bethe primary cause of impairment at baseline;

  6. Medications use affecting gut microbiota such as antibiotics and probiotics threemonths before WMT.

  7. Other neurologic disorders other than TS that could influence the evaluation oftics.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Washed Microbiota Transplantation
Phase: 1
Study Start date:
April 17, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

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

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • Fmt-Dt-N-27/1350

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • SIR RUN RUN hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

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