Selective Microbiota Transplantation for Tourette's Syndrome

Tourette Syndrome Clinical Trial

— mini-FMT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764748
• Other study ID #: SMT-YJ-201701
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 17, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: September 2019
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD; PHD
• Phone: 025-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	Fmt-Dt-N-27/1350	Nanjing	Jiangsu
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Faming Zhang

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Hoffman BU, Lumpkin EA. A gut feeling. Science. 2018 Sep 21;361(6408):1203-1204. doi: 10.1126/science.aau9973. — View 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. — View 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. Erratum in: Eur Child Adolesc Psychiatry. 2011 Jul;20(7):377. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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