Washed Microbiota Transplantation for Attention-deficit/hyperactivity Disorder

Nanjing Medical University

Status and phase: Enrolling; Phase 1

Conditions: Attention-deficit/Hyperactivity Disorder

Treatments: Drug: washed microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06376331

ADHD20240403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Washed microbiota transplantation

Experimental group

Description:

WMT

Treatment:

Drug: washed microbiota transplantation