Washed Microbiota Transplantation for Tourette's Syndrome

Official title

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

Overview

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

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.

Interventions

• Drug Washed Microbiota Transplantation
  The prepared microbiota suspension was infused into the participates' lower gut.

Primary outcome measures

• 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]

Secondary outcome measures (6)

• the Clinical Global Impressions-Improvement scale [Time frame: 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation]
• 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 change of The Swanson, Nolan, and Pelham IV Scale (SNAP-IV) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation]
• change of the Sleep Disturbance Scale for Children (SDSC) [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation]
• change of the Gastrointestinal Symptom Rating Scale (GSRS) . [Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation]
• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affi — Nanjing
• SIR RUN RUN hospital of Nanjing Medical University — Nanjing

Publications

• Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. No abstract available. PMID 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. PMID 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. PMID 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. PMID 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. PMID 29691757

Identifiers

NCT: NCT03764748 · WMT-TS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗