An observational study in Attention-deficit/Hyperactivity Disorder, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 2 sites in China. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
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.
Gut microbiota dysbiosis has been reported to play a critical role in the initiation and progression of neurodevelopmental disorders like ADHD via the gut-brain axis. Therapies targeting gut microbiota including including probiotics, prebiotics and fecal microbiota transplantation (FMT) might provide new insight into the management of ADHD. FMT has been reported to be a highly effective therapy to restore the gut microbiota dysbiosis by transferring gut microbiota from healthy donors to patients. The newly improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the FMT-standardization study group. FMT has shown treatment potential in several gut-brain axis-related disorders, such as amyotrophic lateral sclerosis and Parkinson's disease, promoting us to investigate its treatment potential for ADHD and its comorbidities. To date, only one case report showed a 22-year-old woman undergoing FMT primarily to treat recurrent Clostridioides difficile infection achieved ADHD symptoms alleviation. However, the efficacy of WMT for ADHD and the underlying mechanisms remain largely unexplored. 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.
Children with an established diagnosis of ADHD aged 3-17 years old
Exclusion Criteria:
WMT
Drug: washed microbiota transplantation
The prepared microbiota suspension was infused into the participates' lower gut.
Also known as: fecal microbiota transplantation
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 transplantation
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 transplantation
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 transplantation
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 transplantation
intestinal barrier
plasma DAO, D-lactic acid and bacterial endotoxin levels
Time frame: baseline, 1 month, 3 months post transplantation
change of Swanson, Nolan and Pelham-IV (SNAP-IV).
It is an 26-item questionnaire that measured three of the ADHD symptoms, inattention, hyperactivity and oppositional defiant disorder. The 26-item checklist is scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3).
Time frame: baseline, 1 month, 3 months post transplantation
Conners' Parent Rating Scale-Revised
ADHD symptoms were also assessed by the Conners' Parent Rating Scale-Revised (CPRS-R). 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.
Time frame: baseline, 1 month, 3 months post transplantation
Plan to share: No
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Attention Deficit Disorder with Hyperactivity→
The Second Hospital of Nanjing Medical University