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Recruiting NCT06030752

WMT for Autism Spectrum Disorder (ASD)

Phase I Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Washed Microbiota Transplantation.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Changes in the Autism Behavior Checklist (ABC) in ASD children [Time frame: baseline, 1 month , 3 months, 6 months post transplantation]
  • Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children [Time frame: baseline, 1 month,3 months, 6 months post transplantation]
Secondary outcome measures (6)
  • Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome. [Time frame: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.]
  • The Sleep Disturbance Scale for Children [Time frame: baseline, 1 month, 3 months, 6 months post transplantation]
  • The Gastrointestinal Symptom Rating Scale [Time frame: baseline, 1 month, 3 months, 6 months post transplantation]
  • Clinical Global Impressions-Improvement [Time frame: baseline, 1 months, 3 months, 6 months post transplantation]
  • The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV) [Time frame: At baseline, 1 month, 3 months and 6 months after WMT]
  • Conners' Parent Rating Scale-Revised (CPRS-R) [Time frame: At baseline, 1 month, 3 months and 6 months after WMT]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affi — Nanjing
  • SIR RUN RUN hospital of Nanjing Medical University — Nanjing

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)00 PMID 35151410
  • 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

Identifiers

NCT: NCT06030752 · WMT-ASD-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗