Using washed microbiota transplantation to treat Tourette's syndrome
Efficacy and Safety of Washed Microbiota Transplantation for Tourette's Syndrome
This study is testing whether a new treatment that involves transferring healthy gut bacteria can help people with Tourette's syndrome feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT03764748 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 6 to 17 who have been diagnosed with Tourette's syndrome and have a significant level of tic severity.
Not a fit: Patients with other severe neurological or psychiatric disorders, or those whose symptoms are primarily due to conditions like autism or obsessive-compulsive disorder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with Tourette's syndrome by reducing tic severity.
How similar studies have performed: While the approach of using microbiota transplantation is gaining traction in treating gut-brain axis-related disorders, this specific application for Tourette's syndrome is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.