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WMT voor autismespectrumstoornis (ASS)

15 september 2026 bijgewerkt door: Faming Zhang, The Second Hospital of Nanjing Medical University

Gewassen microbiota-transplantatie (WMT) voor autismespectrumstoornis (ASS)

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

80

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Werving
        • Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China
        • Werving
        • SIR RUN RUN hospital of Nanjing Medical University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

3 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.

Beschrijving

Inclusion Criteria:

  • Children and adolescents with an established diagnosis of ASD 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Washed microbiota transplantation

WMT
Geneesmiddel: Washed Microbiota Transplantation

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

Andere namen:
  • Fecale microbiota-transplantatie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in the Autism Behavior Checklist (ABC) in ASD children
Tijdsspanne: baseline, 1 month , 3 months, 6 months post transplantation

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

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
Tijdsspanne: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.

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.
The Sleep Disturbance Scale for Children
Tijdsspanne: baseline, 1 month, 3 months, 6 months post transplantation

The Sleep Disturbance Scale for Children (SDSC) was used to assess sleep quality in children with ASD. It had 26 items, each with a score from 0-4. Higher SDSC scores indicated poorer sleep quality
baseline, 1 month, 3 months, 6 months post transplantation
The Gastrointestinal Symptom Rating Scale
Tijdsspanne: baseline, 1 month, 3 months, 6 months post transplantation

The Gastrointestinal Symptom Rating Scale (GSRS) was used to assess gastrointestinal symptoms. It was a 7-point Likert scale questionnaire with 15 items. The 15 items can be divided into 5 dimensions: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items), and constipation (3 items).
baseline, 1 month, 3 months, 6 months post transplantation
Clinical Global Impressions-Improvement
Tijdsspanne: baseline, 1 months, 3 months, 6 months post transplantation

The Clinical Global Impressions-Improvement (CGI-I) evaluated by experienced clinician was used to assess the symptom changes relative to baseline, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse) [26]. CGI-I = 1 or 2 was considered a clinical response.
baseline, 1 months, 3 months, 6 months post transplantation
The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)
Tijdsspanne: At baseline, 1 month, 3 months and 6 months after WMT

It was a 26-item questionnaire that measured three of the ADHD symptoms, inattention (items 1-9), hyperactivity (items 10-18), and oppositional defiant disorder (items 19-26). The 26-item checklist was scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3).
At baseline, 1 month, 3 months and 6 months after WMT
Conners' Parent Rating Scale-Revised (CPRS-R)
Tijdsspanne: At baseline, 1 month, 3 months and 6 months after WMT

The CPRS-R was composed of 10 items derived from the Revised Conners Parent Rating Scale. It used a 4-point Likert scale (range: 0-30), with higher scores indicating more severe symptoms.
At baseline, 1 month, 3 months and 6 months after WMT

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Second Hospital of Nanjing Medical University

Medewerkers

Nanjing Medical University

Onderzoekers

  • Hoofdonderzoeker: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 september 2023

Primaire voltooiing (Geschat)

4 april 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

25 mei 2023

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2023

Eerst geplaatst (Werkelijk)

11 september 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WMT-ASD-2023

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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