Washed Microbiota Transplantation for Tourette's Syndrome
ConditionTourette Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-17
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients were aged 6 to 17 years (inclusive);
Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for TS;
Had a Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) of at least 20 at screening and baseline.
Underwent WMT.
Disqualifiers
Complicated with certain brain disease, including tumor,injury,cerebrovascular disease;
Complicated with other severe disease, including cancers, organ failure, heart diseases;
Stereotypy associated with autism spectrum disorder;
With a confirmed diagnosis of psychiatric diseases, such as bipolar disorders; schizophrenia and major depressive disorders;
Trial design
Design model
Single group
Treatments tested in this trial
Washed Microbiota Transplantation
DrugThe prepared microbiota suspension was infused into the participates' lower gut.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Washed microbiota transplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS)
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).
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantationSecondary outcomes
1
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.
Time frame
4 weeks, 8 weeks, 12 weeks, 6 months post transplantation2
the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score
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.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation3
the change of The Swanson, Nolan, and Pelham IV Scale (SNAP-IV)
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).
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation4
change of the Sleep Disturbance Scale for Children (SDSC)
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.
Time frame
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
Source ClinicalTrials.gov