WMT for Autism Spectrum Disorder (ASD)

Autism Spectrum Disorder Clinical Trial

Official title:

Washed Microbiota Transplantation (WMT) for Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030752
• Other study ID #: WMT-ASD-2023
• Status: Recruiting
• Phase: Phase 1
• Start date: September 20, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: September 2023
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in autism spectrum disorder; To study the potential etiological mechanism of autism spectrum disorder.

Description:

Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2026
• Est. primary completion date: April 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria.

• Age 3-14years.

Exclusion Criteria:

• ASD children with severe gastrointestinal symptoms or organic disease requiring immediate surgery or treatment.

• ASD children who have received antibiotics within 3 months, or are receiving immunosuppressive agents and biologics.

• ASD children with underlying diseases, such as severe anemia, malnutrition, autoimmune diseases (autoimmune thyroiditis, type I diabetes, etc.), allergic diseases (asthma, severe eczema, etc.), central nervous system diseases, metabolic syndrome, etc.

• ASD children with other organic dysfunctions, such as cerebral palsy, congenital genetic diseases, etc.; history of other psychiatric-behavioral disorders, genetic-metabolic diseases and other major physical diseases; other physical diseases, such as hearing impairment, vocal disorders, blindness, etc.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Washed Microbiota Transplantation
The prepared microbiota suspension was infused into the participates' lower gut.

Locations

Country	Name	City	State
China	Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	SIR RUN RUN hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	SIR RUN RUN hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (12)

Brugha TS, Spiers N, Bankart J, Cooper SA, McManus S, Scott FJ, Smith J, Tyrer F. Epidemiology of autism in adults across age groups and ability levels. Br J Psychiatry. 2016 Dec;209(6):498-503. doi: 10.1192/bjp.bp.115.174649. Epub 2016 Jul 7. — View Citation

Chen Y, Fang H, Li C, Wu G, Xu T, Yang X, Zhao L, Ke X, Zhang C. Gut Bacteria Shared by Children and Their Mothers Associate with Developmental Level and Social Deficits in Autism Spectrum Disorder. mSphere. 2020 Dec 2;5(6):e01044-20. doi: 10.1128/mSphere.01044-20. — View Citation

Hirota T, King BH. Autism Spectrum Disorder: A Review. JAMA. 2023 Jan 10;329(2):157-168. doi: 10.1001/jama.2022.23661. — View Citation

Hung LY, Margolis KG. Autism spectrum disorders and the gastrointestinal tract: insights into mechanisms and clinical relevance. Nat Rev Gastroenterol Hepatol. 2024 Mar;21(3):142-163. doi: 10.1038/s41575-023-00857-1. Epub 2023 Dec 19. — View Citation

Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, Meyenberg C, Wiese T, Deol-Bhullar G, Wandel C, Ashford E, Anagnostou E. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet Psychiatry. 2022 Mar;9(3):199-210. doi: 10.1016/S2215-0366(21)00429-6. Epub 2022 Feb 10. — View Citation

Khachadourian V, Mahjani B, Sandin S, Kolevzon A, Buxbaum JD, Reichenberg A, Janecka M. Comorbidities in autism spectrum disorder and their etiologies. Transl Psychiatry. 2023 Feb 25;13(1):71. doi: 10.1038/s41398-023-02374-w. — View Citation

Liang X, Haegele JA, Tse AC, Li M, Zhang H, Zhao S, Li SX. The impact of the physical activity intervention on sleep in children and adolescents with autism spectrum disorder: A systematic review and meta-analysis. Sleep Med Rev. 2024 Apr;74:101913. doi: 10.1016/j.smrv.2024.101913. Epub 2024 Feb 23. — View Citation

Liu NH, Liu HQ, Zheng JY, Zhu ML, Wu LH, Pan HF, He XX. Fresh Washed Microbiota Transplantation Alters Gut Microbiota Metabolites to Ameliorate Sleeping Disorder Symptom of Autistic Children. J Microbiol. 2023 Aug;61(8):741-753. doi: 10.1007/s12275-023-00069-x. Epub 2023 Sep 4. — View Citation

Nanjing consensus on methodology of washed microbiota transplantation. Chin Med J (Engl). 2020 Oct 5;133(19):2330-2332. doi: 10.1097/CM9.0000000000000954. No abstract available. — View Citation

Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2. — View Citation

Wan Y, Zuo T, Xu Z, Zhang F, Zhan H, Chan D, Leung TF, Yeoh YK, Chan FKL, Chan R, Ng SC. Underdevelopment of the gut microbiota and bacteria species as non-invasive markers of prediction in children with autism spectrum disorder. Gut. 2022 May;71(5):910-918. doi: 10.1136/gutjnl-2020-324015. Epub 2021 Jul 26. — View Citation

Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Autism Behavior Checklist (ABC) in ASD children	ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism.	baseline, 4 weeks , 8 weeks , 3 month, 6 months post transplantation
Primary	Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children	ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms.	baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation
Secondary	Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.	The composition of the gut microbe was evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between the two at the phylum, genus and species levels of the intestinal flora and control children, and to develop a model for predicting the structure of the flora.	Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
Secondary	Parental Global Impressions-Revised	The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.	baseline, 2 weeks , 6 weeks , 10 month, 1 months , 2 months, 3 months, 6 months post transplantation