Washed Microbiota Transplantation for Tourette's Syndrome

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Dec 3, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for Tourette's syndrome (TS) called washed microbiota transplantation (WMT). The goal is to see if this method can help reduce the tics that people with TS experience. The trial is currently looking for participants aged 6 to 17 years who have been diagnosed with TS and have a certain level of tic severity, as measured by a specific scale.

To be eligible for the trial, participants must not have other serious health issues, like certain brain diseases or severe psychiatric conditions. If someone is interested in joining, they can expect to undergo the WMT procedure, which involves using specially prepared gut bacteria to potentially improve their symptoms. This study aims to gather important information on how effective this treatment can be for young people with Tourette's syndrome.

Gender

ALL

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.