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NCT Number: NCT03764748

Washed Microbiota Transplantation for Tourette's Syndrome

This study aimed to evaluate the efficacy of washed microbiota transplantation in the treatment of Tourette's syndrome (TS).

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

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About this study

Emerging scientific data support the significant role of microbiota in the modulation of the central nervous system. The reconstitution of gut microbiota might be a potential option to treat Tourette's syndrome (TS). FMT has been reported to be a highly effective therapy to restore the gut microbiota dysbiosis by transferring gut microbiota from healthy donors to patients. The newly improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the FMT-standardization study group. FMT has shown treatment potential in several gut-brain axis-related disorders, such as amyotrophic lateral sclerosis and Parkinson's disease, promoting us to investigate its treatment potential for Tourette's syndrome. In this study, investigators aimed to evaluate the efficacy of WMT for Tourette's syndrome and its comorbidities using specialized questionnaires for Tourette's syndrome and investigate the underlying mechanism.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion criteria

  • 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.

Treatment and study plan

Washed Microbiota Transplantation

Drug

The prepared microbiota suspension was infused into the participates' lower gut.

Other names: Fecal microbiota transplantation

Primary outcomes

  1. The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    The YGTSS rating scale is a semistructured clinician- or investigator-administered rating instrument in which participants or caregivers evaluate the number, frequency, intensity, complexity, and interference of motor and phonic tics in the prior week on a 6-point scale from 0 (none) to 5 (severe) [1]. The total Motor Tic Severity Score (MTSS; 0-25 points) is added to the total Vocal Tic Severity Score (VTSS; 0-25 points) to determine the TTS (0-50 points).

Secondary outcomes

  1. the Clinical Global Impressions-Improvement scale

    Time frame: 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    Positive treatment response was defined by a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impressions-Improvement scale. The Clinical Global Impression - Improvement scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:1.Very much improved; 2.Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7.Very much worse.

  2. the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    The Gilles de la Tourette Syndrome Quality-of-Life Scale with 27 items addresses the issue of how the illness affects patients' well-being. It ranges from 0 to108, and higher values represent a worse outcome.

  3. the change of The Swanson, Nolan, and Pelham IV Scale (SNAP-IV)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    It is an 26-item questionnaire that measured three of the ADHD symptoms, inattention, hyperactivity and oppositional defiant disorder. The 26-item checklist is scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3).

  4. change of the Sleep Disturbance Scale for Children (SDSC)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    The SDSC was 26-item test measuring sleep problems and each item received a value from 0 to 4, with higher scores indicating more severe sleep disorders.

  5. change of the Gastrointestinal Symptom Rating Scale (GSRS) .

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

    It is based on 15 questions which are scored into 5 domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item weights from 1 to 7, with higher scores reflecting more severe symptoms.

  6. the difference of the gut microbe composition between individuals with TS and healthy children by sequencing faecal metagenome.

    Time frame: baseline, 12 weeks, 6 months post transplantation

    The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between individuals with TS and control children at the phylum, genus and species levels of the intestinal flora, and to develop a model for predicting the structure of the flora.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, MD; PHD

CONTACT

[email protected]

025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Nanjing Medical University

Registry information

Official study title

Efficacy and Safety of Washed Microbiota Transplantation for Tourette's Syndrome

Acronym: WMT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2018
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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