Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
Aged 3-17;
Received stable treatments for ≥1 month preceding WMT;
Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT.
Disqualifiers
Unable to understand the questionnaires or provide informed consent by the guardian;
Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis;
Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer;
Accompanied with other life-threatening disorders required emergency treatment;
Trial population
Children with an established diagnosis of ADHD aged 3-17 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
washed microbiota transplantation
DrugThe prepared microbiota suspension was infused into the participates' lower gut.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Washed microbiota transplantation1 intervention
Trial outcomes
Primary outcomes
1
Clinical Global Impressions-Improvement (CGI-I)
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). CGI-I = 1 or 2 was considered a clinical response.
Time frame
1 month, 3 months post transplantationSecondary outcomes
1
change of the Sleep Disturbance Scale for Children (SDSC).
The SDSC is 26-item test measuring sleep problems and each item receives a value from 1 to 5, with higher scores indicating more severe sleep disorders.
Time frame
baseline, 1 month, 3 months post transplantation2
change of the Gastrointestinal Symptom Rating Scale (GSRS) .
It is based on 15 questions which are scored into 5 domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item weights from 1 to 7, with higher scores reflecting more severe symptoms.
Time frame
baseline, 1 month, 3 months post transplantation3
the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome.
The composition of the gut microbiota is 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.
Time frame
baseline, 1 month, 3 months post transplantation4
intestinal barrier
plasma DAO, D-lactic acid and bacterial endotoxin levels
Time frame
baseline, 1 month, 3 months post transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
Source ClinicalTrials.gov