Clinical trial NCT03764748: Washed Microbiota Transplantation for Tourette's Syndrome
Official title: Efficacy and Safety of Washed Microbiota Transplantation for Tourette's Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Tourette Syndrome
Keywords: Tic Disorders
Gut microbiota
Brain-gut axis
Washed Microbiota Transplantation
Tourette syndrome
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2018-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: The change of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
Secondary outcomes:
measure: the Clinical Global Impressions-Improvement scale
timeFrame: 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: the change of The Swanson, Nolan, and Pelham IV Scale (SNAP-IV)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: change of the Sleep Disturbance Scale for Children (SDSC)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: change of the Gastrointestinal Symptom Rating Scale (GSRS) .
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: the difference of the gut microbe composition between individuals with TS and healthy children by sequencing faecal metagenome.
timeFrame: baseline, 12 weeks, 6 months post transplantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: SIR RUN RUN hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, MD; PHD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.