Selective Microbiota Transplantation for Tourette's Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Drug: mini-FMT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mini-FMT<br>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. | Drug: mini-FMT<br>* 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) will be delivered daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.<br>* Other names: Selective microbiota transplantation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Yale Global Tic Severity Scale total score | The change of tic severity according to the Yale Global Tic Severity Scale total score at 8 weeks after treatment. Yale Global Tic Severity Scale total score ranges 0-100, and higher values represent a worse outcome. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Clinical Global Impressions-Improvement scale | Positive treatment response was defined by a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impressions-Improvement scale. The Clinical Global Impression - Improvement scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:1.Very much improved; 2.Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7.Very much worse. The Clinical Global Impressions-Improvement scale score will recorded at week 8 after treatment. | 8 weeks | 
| the change of Clinical Global Impression-Severity | The Clinical Global Impression-Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1.Normal, not at all; 2.Borderline mentally; 3. Mildly; 4.Moderately; 5. Markedly; 6. Severely; 7. Among the most extremely. The change of Clinical Global Impression-Severity will be recorded at week 8 after treatment. | 8 weeks | 
| the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score | The Gilles de la Tourette Syndrome Quality-of-Life Scale addresses the issue of how the illness affects patients' well-being. It ranges from 0 to108, and higher values represent a worse outcome. The change of life quality according to the Gilles de la Tourette Syndrome Quality-of-Life Scale score at 1 week, 2 weeks and 8 weeks after treatment.The change of Gilles de la Tourette Syndrome Quality-of-Life Scale score will be recorded at week 8 after treatment. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tic Disorders, Gut microbiota, Brain-gut axis, Microbiota Transplantation, Tourette syndrome