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

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ClinicalTrials.gov Identifier: NCT03764748
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

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

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: mini-FMT Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Selective Microbiota Transplantation for Tourette's Syndrome
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


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 Name: Selective microbiota transplantation




Primary Outcome Measures :
  1. The change of Yale Global Tic Severity Scale total score [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. the Clinical Global Impressions-Improvement scale [ Time Frame: 8 weeks ]
    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.

  2. the change of Clinical Global Impression-Severity [ Time Frame: 8 weeks ]
    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.

  3. the change of Gilles de la Tourette Syndrome Quality-of-Life Scale score [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764748


Contacts
Contact: Faming Zhang, MD; PHD 025-58509883 fzhang@njmu.edu.cn
Contact: Xiao Ding, MD 86-15250963899 xding@njmu.edu.cn

Locations
China, Jiangsu
Fmt-Dt-N-27/1350 Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, PhD,MD    86-025-58509883    fzhang@njmu.edu.cn   
Principal Investigator: Faming Zhang, MD,PhD         
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
Faming Zhang
Investigators
Study Chair: Faming Zhang, MD; PHD The Second Hospital of Nanjing Medical University

Publications:
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03764748     History of Changes
Other Study ID Numbers: SMT-YJ-201701
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Tic Disorders
Gut microbiota
Brain-gut axis
Microbiota Transplantation
Tourette syndrome

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders