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New treatment option for Tourette Syndrome
Official title Washed Microbiota Transplantation for Tourette's Syndrome
ClinicalTrials.gov ID: NCT03764748
What this study is testing
What is Washed Microbiota Transplantation?
Washed Microbiota Transplantation is an investigational medicine, being studied as a potential treatment for tourette syndrome.
Also referred to as Fecal microbiota transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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;
- Clinically significant obsessive-compulsive disorder at baseline considered to be the primary cause of impairment at baseline;
- Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT.
See the full eligibility criteria
- 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.
- 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;
- Clinically significant obsessive-compulsive disorder at baseline considered to be the primary cause of impairment at baseline;
- Medications use affecting gut microbiota such as antibiotics and probiotics three months before WMT.
- Other neurologic disorders other than TS that could influence the evaluation of tics.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.