Selective Microbiota Transplantation for Tourette’s Syndrome

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Brief Title

Selective Microbiota Transplantation for Tourette's Syndrome

Official Title

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

Brief Summary

      This study aimed to evaluate the role of selective microbiota transplantation on 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's syndrome (TS). This study aims to evaluate the role of selective microbiota
      transplantation on Tourette's syndrome (TS). Patients aged 7 to 60 years old with TS and a
      Yale Global Tic Severity Scale (YGTSS) -total tic score ≥20 will be enrolled in this
      open-label clinical trial. Participants will receive 200ml selective microbiota suspension
      (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal
      transendoscopic enteral tubing (TET) tube for 3 days. Clinical evaluations before, 1, 4 and 8
      weeks after mini-FMT will be assessed with the YGTSS, the Gilles de la Tourette Syndrome
      Quality-of-Life Scale (GTS-QOL), the Clinical Global Impression (CGI)-Severity, the
      Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Beck Depression Inventory (BDI) and the
      Beck Anxiety Inventory (BAI). 16S rRNA stool analysis will be performed to assess associated
      microbial changes. The urinary metabolic profiles of those patients will be generated using
      nuclear magnetic resonance (NMR) spectroscopy. Safety will be assessed in all patients after
      treatment.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

The change of Yale Global Tic Severity Scale total score

Secondary Outcome

 the Clinical Global Impressions-Improvement scale

Condition

Tourette Syndrome

Intervention

mini-FMT

Study Arms / Comparison Groups

 mini-FMT
Description:  Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

April 17, 2017

Completion Date

October 31, 2020

Primary Completion Date

October 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  7-60 years old with Tourette or chronic tic disorder of moderate or greater severity
             as measured by a Yale Global Tic Severity Scale-Total score>25

        Exclusion Criteria:

          -  Complicated with certain brain disease, including tumor,injury,cerebrovascular
             disease;

          -  Complicated with other severe disease, including cancers, organ failure, heart
             diseases;

          -  Follow-up less than 8 weeks.

Gender

All

Ages

7 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Faming Zhang, MD; PHD, 025-58509883, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03764748

Organization ID

SMT-YJ-201701

Responsible Party

Sponsor-Investigator

Study Sponsor

Faming Zhang

Study Sponsor

Faming Zhang, MD; PHD, Study Chair, The Second Hospital of Nanjing Medical University

Verification Date

September 2019