Washed Microbiota Transplantation for Tourette's Syndrome

NCT ID: NCT03764748

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2027-10-31

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.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Washed microbiota transplantation

WMT

Group Type: EXPERIMENTAL

Washed Microbiota Transplantation

Intervention Type: DRUG

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

Interventions

Washed Microbiota Transplantation

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

Intervention Type: DRUG

Other Intervention Names

Fecal microbiota transplantation

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD; PHD

Role: STUDY_CHAIR

The Second Hospital of Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD; PHD

Role: CONTACT

fzhang@njmu.edu.cn

025-58509883

Facility Contacts

Faming Zhang, PhD,MD

Role: primary

fzhang@njmu.edu.cn

86-025-58509883

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

086-25-58509883

References

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

Reference Type: BACKGROUND

PMID: 30237346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28870296 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21445724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27556065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29691757 (View on PubMed)

Other Identifiers

WMT-TS

Identifier Type: -

Identifier Source: org_study_id