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Tourette SyndromePhase 1WMTNCT03764748

Washed Microbiota Transplantation for Tourette's Syndrome

A Phase 1 study testing Washed Microbiota Transplantation in people with Tourette Syndrome, run by The Second Hospital of Nanjing Medical University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Tourette Syndrome
What is being tested?
Washed Microbiota Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
17 Apr 2024to 31 Oct 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Faming Zhang, MD; PHD contact

025-58509883

fzhang@njmu.edu.cn

China2 sites, 2 recruiting

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

    Nanjing, Jiangsu, 210011

    Faming Zhang, PhD,MD, 86-025-58509883, fzhang@njmu.edu.cn

    Faming Zhang, MD,PhD

    Recruiting

  • SIR RUN RUN hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

    Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of 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).

Read the detailed description

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.

Being tested
Washed Microbiota Transplantation
Keywords
Tic Disorders, Gut microbiota, Brain-gut axis, Washed Microbiota Transplantation, Tourette syndrome
Medical subject headings
Tourette Syndrome, Tic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Washed Microbiota TransplantationDrug

    Also called Fecal microbiota transplantation

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

Study groups in NCT03764748
Study groupRoleWhat they receive
Washed microbiota transplantationExperimentalWMT
Receives: Drug: Washed Microbiota Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

Secondary outcomes (6)

  1. the Clinical Global Impressions-Improvement scale

    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.

    Measured: 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

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

    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.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

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

    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).

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

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

    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.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

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

    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.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation

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

    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.

    Measured: baseline, 12 weeks, 6 months post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start17 Apr 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764748
Sponsor's protocol ID
WMT-TS
Acronym
WMT
Status last verified
Aug 2024
First submitted
30 Nov 2018
Last updated
19 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. No abstract available.

    PubMed 30237346

  • Foster JA. Targeting the Microbiome for Mental Health: Hype or Hope? Biol Psychiatry. 2017 Oct 1;82(7):456-457. doi: 10.1016/j.biopsych.2017.08.002. No abstract available.

    PubMed 28870296

  • Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.

    PubMed 21445724

  • Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.

    PubMed 27556065

  • Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.

    PubMed 29691757

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Washed Microbiota Transplantation in people with Tourette Syndrome, run by The Second Hospital of Nanjing Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, MD; PHD (025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764748, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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