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