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Clinical Trial Summary

This study aimed to evaluate the role of selective microbiota transplantation on Tourette's syndrome (TS).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03764748
Study type Interventional
Source The Second Hospital of Nanjing Medical University
Contact Faming Zhang, MD; PHD
Phone 025-58509883
Email fzhang@njmu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date April 17, 2017
Completion date October 31, 2020

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