Selective Microbiota Transplantation for Tourette's Syndrome (mini-FMT)

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

This study aimed to evaluate the role of selective microbiota transplantation on Tourette's syndrome (TS).

Study Overview

• Status: Unknown
• Conditions: Tourette Syndrome
• Intervention / Treatment: Drug: mini-FMT

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). This study aims to evaluate the role of selective microbiota transplantation on Tourette's syndrome (TS). Patients aged 7 to 60 years old with TS and a Yale Global Tic Severity Scale (YGTSS) -total tic score ≥20 will be enrolled in this open-label clinical trial. Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days. Clinical evaluations before, 1, 4 and 8 weeks after mini-FMT will be assessed with the YGTSS, the Gilles de la Tourette Syndrome Quality-of-Life Scale (GTS-QOL), the Clinical Global Impression (CGI)-Severity, the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI). 16S rRNA stool analysis will be performed to assess associated microbial changes. The urinary metabolic profiles of those patients will be generated using nuclear magnetic resonance (NMR) spectroscopy. Safety will be assessed in all patients after treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Faming Zhang, MD; PHD; Phone Number: 025-58509883; Email: fzhang@njmu.edu.cn
• Study Contact Backup: Name: Xiao Ding, MD; Phone Number: 86-15250963899; Email: xding@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Fmt-Dt-N-27/1350
      • Contact: Faming Zhang, PhD,MD; Phone Number: 86-025-58509883; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 7-60 years old with Tourette or chronic tic disorder of moderate or greater severity as measured by a Yale Global Tic Severity Scale-Total score>25

Exclusion Criteria:

• Complicated with certain brain disease, including tumor,injury,cerebrovascular disease;
• Complicated with other severe disease, including cancers, organ failure, heart diseases;
• Follow-up less than 8 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mini-FMT; Participants will receive 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.	Drug: mini-FMT; 200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) will be delivered daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.; Other Names: Selective microbiota transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Yale Global Tic Severity Scale total score	The change of tic severity according to the Yale Global Tic Severity Scale total score at 8 weeks after treatment. Yale Global Tic Severity Scale total score ranges 0-100, and higher values represent a worse outcome.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The Clinical Global Impressions-Improvement scale score will recorded at week 8 after treatment.	8 weeks
the change of Clinical Global Impression-Severity	The Clinical Global Impression-Severity scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 1.Normal, not at all; 2.Borderline mentally; 3. Mildly; 4.Moderately; 5. Markedly; 6. Severely; 7. Among the most extremely. The change of Clinical Global Impression-Severity will be recorded at week 8 after treatment.	8 weeks
the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score	The Gilles de la Tourette Syndrome Quality-of-Life Scale addresses the issue of how the illness affects patients' well-being. It ranges from 0 to108, and higher values represent a worse outcome. The change of life quality according to the Gilles de la Tourette Syndrome Quality-of-Life Scale score at 1 week, 2 weeks and 8 weeks after treatment.The change of Gilles de la Tourette Syndrome Quality-of-Life Scale score will be recorded at week 8 after treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Faming Zhang
• Investigators: Study Chair: faming zhang, MD; PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Eur Child Adolesc Psychiatry. 2011 Jul;20(7):377.
• Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 21, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Gut microbiota; Tourette syndrome; Tic Disorders; Brain-gut axis; Microbiota Transplantation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: SMT-YJ-201701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No