Using washed microbiota transplantation to treat Tourette's syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy of washed microbiota transplantation (WMT) as a treatment for Tourette's syndrome (TS). It is based on emerging evidence that gut microbiota can influence the central nervous system, suggesting that restoring gut microbiota may help alleviate TS symptoms. The study involves transferring gut microbiota from healthy donors to patients using a specialized washing process to enhance the treatment's effectiveness. Participants will be assessed using standardized questionnaires to measure the impact of WMT on TS and its comorbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• SIR RUN RUN hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Faming Zhang, MD; PHD
• Email: fzhang@njmu.edu.cn
• Phone: 025-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.