NCT03764748 Washed Microbiota Transplantation for Tourette's Syndrome
| NCT ID | NCT03764748 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Tourette Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-04-17 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).
Eligibility 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.
Contact & Investigator
Faming Zhang, MD; PHD
STUDY CHAIR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT03764748 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Tourette Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03764748 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03764748 currently recruiting?
Yes, NCT03764748 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT03764748 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT03764748 clinical trial?
NCT03764748 is sponsored by The Second Hospital of Nanjing Medical University. The principal investigator is Faming Zhang, MD; PHD at The Second Hospital of Nanjing Medical University. The trial plans to enroll 30 participants.