Tourette Syndrome
Conditions
Keywords
Tic Disorders, Gut microbiota, Brain-gut axis, Washed Microbiota Transplantation, Tourette syndrome
Brief summary
This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of 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). 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.
Interventions
The prepared microbiota suspension was infused into the participates' lower gut.
Sponsors
Nanjing Medical University
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients were aged 6 to 17 years (inclusive); 2. Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for TS; 3. Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 at screening and baseline. 4. Underwent WMT.
Exclusion criteria
1. Complicated with certain brain disease, including tumor,injury,cerebrovascular disease; 2. Complicated with other severe disease, including cancers, organ failure, heart diseases; 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 be the primary cause of impairment at baseline; 6. Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT. 7. Other neurologic disorders other than TS that could influence the evaluation of tics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) | baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | The YGTSS rating scale is a semistructured clinician- or investigator-administered rating instrument in which participants or caregivers evaluate the number, frequency, intensity, complexity, and interference of motor and phonic tics in the prior week on a 6-point scale from 0 (none) to 5 (severe) \[1\]. The total Motor Tic Severity Score (MTSS; 0-25 points) is added to the total Vocal Tic Severity Score (VTSS; 0-25 points) to determine the TTS (0-50 points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score | baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | The Gilles de la Tourette Syndrome Quality-of-Life Scale with 27 items 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 The Swanson, Nolan, and Pelham IV Scale (SNAP-IV) | baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | It is an 26-item questionnaire that measured three of the ADHD symptoms, inattention, hyperactivity and oppositional defiant disorder. The 26-item checklist is scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3). |
| the Clinical Global Impressions-Improvement scale | 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | 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. |
| change of the Gastrointestinal Symptom Rating Scale (GSRS) . | baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | It is based on 15 questions which are scored into 5 domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item weights from 1 to 7, with higher scores reflecting more severe symptoms. |
| the difference of the gut microbe composition between individuals with TS and healthy children by sequencing faecal metagenome. | baseline, 12 weeks, 6 months post transplantation | The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between individuals with TS and control children at the phylum, genus and species levels of the intestinal flora, and to develop a model for predicting the structure of the flora. |
| change of the Sleep Disturbance Scale for Children (SDSC) | baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation | The SDSC was 26-item test measuring sleep problems and each item received a value from 0 to 4, with higher scores indicating more severe sleep disorders. |
Countries
China
Contacts
Primary ContactFaming Zhang, MD; PHD
Outcome results
None listed