Washed Microbiota Transplantation for Tourette's Syndrome

NCT03764748 | Recruiting Phase 1

• 1 other identifier: WMT-TS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tourette Syndrome

Keywords

Tic Disorders; Gut microbiota; Brain-gut axis; Washed Microbiota Transplantation; Tourette syndrome

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (6)

• the Clinical Global Impressions-Improvement scale

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

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

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

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

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

• change of the Sleep Disturbance Scale for Children (SDSC)

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

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

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

Study Arms (1)

Washed microbiota transplantation

EXPERIMENTAL

WMT

Drug: Washed Microbiota Transplantation

Interventions

Washed Microbiota Transplantation DRUG

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

Also known as: Fecal microbiota transplantation

Washed microbiota transplantation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Nanjing Medical University: collaborator

Study Sites (2)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, MD; PHD

  The Second Hospital of Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Faming Zhang, MD; PHD

CONTACT

025-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: April 17, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (2)