Clinical trial NCT06376331: Washed Microbiota Transplantation for Attention-deficit/hyperactivity Disorder
Official title: Washed Microbiota Transplantation for Attention-deficit/hyperactivity Disorder and Its Comorbidities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: attention-deficit/hyperactivity disorder
washed microbiota transplantation
fecal microbiota transplantation
sleep disturbance
gut-brain axis
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2024-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
2. Aged 5-17;
3. stable treatments one month before 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

Primary outcomes:
measure: change of Swanson, Nolan and Pelham-IV (SNAP-IV).
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ).
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
Secondary outcomes:
measure: change of the Sleep Disturbance Scale for Children (SDSC).
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: change of the Gastrointestinal Symptom Rating Scale (GSRS) .
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome.
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: the difference of the serum neurotransmitters between children with ADHD and healthy children
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
measure: intestinal barrier
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 6 months post transplantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: SIR RUN RUN hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
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