Clinical trial
Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities
Name
ADHD20240403
Description
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism.
Trial arms
Trial start
2024-04-20
Estimated PCD
2027-06-01
Trial end
2027-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
washed microbiota transplantation
The prepared microbiota suspension was infused into the participates' lower gut.
Arms:
Washed microbiota transplantation
Other names:
fecal microbiota transplantation
Size
50
Primary endpoint
change of Swanson, Nolan and Pelham-IV (SNAP-IV).
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ).
baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
Eligibility criteria
Inclusion Criteria:
1. Children with an established diagnosis of ASD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
2. Aged 6-17;
3. Underwent WMT;
4. Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT.
Exclusion Criteria:
1. Unable to understand the questionnaires or provide informed consent by the guardian;
2. Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis;
3. Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer;
4. Accompanied with other life-threatening disorders required emergency treatment;
5. Used to undergo FMT in other medical centers;
6. Unable to tolerate colonoscopy or anesthesia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-24
1 organization