WMT for Autism Spectrum Disorder (ASD)

NCT06030752 | Recruiting Phase 1

• 1 other identifier: WMT-ASD-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD traits. 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 ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.

Conditions

Autism Spectrum Disorder

Keywords

fecal Microbiota Transplantation; Autism spectrum disorder; Gut microbiota; Gut-brain axis

Outcome Measures

Primary Outcomes (2)

• 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, 1 month , 3 months, 6 months post transplantation

• 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, 1 month,3 months, 6 months post transplantation

Secondary Outcomes (6)

• Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.

  Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.

• The Sleep Disturbance Scale for Children

  baseline, 1 month, 3 months, 6 months post transplantation

• The Gastrointestinal Symptom Rating Scale

  baseline, 1 month, 3 months, 6 months post transplantation

• Clinical Global Impressions-Improvement

  baseline, 1 months, 3 months, 6 months post transplantation

• The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)

  At baseline, 1 month, 3 months and 6 months after WMT

Study Arms (1)

Washed microbiota transplantation

EXPERIMENTAL

WMT

Drug: Washed Microbiota Transplantation

Interventions

Washed Microbiota Transplantation DRUG

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

Also known as: Fecal Microbiota Transplantation

Washed microbiota transplantation

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents with an established diagnosis of ADHD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
• Age 3-17 years.
• Received stable treatments for ≥1 month preceding WMT

You may not qualify if:

• Their guardian could not understand the questionnaires or provide informed consent.
• Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
• Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
• Accompanied with other life-threatening disorders required emergency treatment.
• Unable to tolerate colonoscopy or anesthesia.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Nanjing Medical University: collaborator

Study Sites (2)

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

Nanjing, Jiangsu, China

RECRUITING

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (12)

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

  PMID: 36625807 BACKGROUND

• 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.

  PMID: 34079068 BACKGROUND

• 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.

  PMID: 27388569 BACKGROUND

• 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.

  PMID: 36841830 BACKGROUND

• 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.

  PMID: 38442500 BACKGROUND

• 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.

  PMID: 33268567 BACKGROUND

• 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.

  PMID: 35151410 BACKGROUND

• 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.

  PMID: 38114585 BACKGROUND

• 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.

  PMID: 37665552 BACKGROUND

• 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.

  PMID: 34312160 BACKGROUND

• 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.

  PMID: 31919742 BACKGROUND

• 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.

  PMID: 32701590 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: September 11, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)