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WMT for Autism Spectrum Disorder (ASD)

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Phase changed: Phase 1 → not specified Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised at 1 of 2 sites
    • Publications: details revised at 12 of 12 entries
  2. Enrollment target: 30 to 80v5 Show 4 more changesShow less
    • Primary completion date: Apr 4, 2026 to Apr 4, 2027
    • Study completion date: May 1, 2026 to May 1, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (6)
  3. Secondary endpoints: 4 to 6
    • Eligibility criteria expanded, about 1 word
    v4
  4. Eligibility criteria shortened, about 34 words
    • Secondary endpoints: 2 to 4
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 1, 2024 to Apr 4, 2026
    • Study completion date: Apr 1, 2024 to May 1, 2026
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06030752
Lead Sponsor The Second Hospital of Nanjing Medical University
Collaborators: Nanjing Medical University
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov