Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06376331

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Sleep Wake Disorders

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Unable to tolerate colonoscopy or anesthesia

Treatment and study plan

Washed Microbiota Transplantation

Drug

The prepared microbiota suspension was infused into the participates' lower gut.

Other names: fecal microbiota transplantation

Primary outcomes

  1. Clinical Global Impressions-Improvement (CGI-I)

    Time frame: 1 month, 3 months post transplantation

    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.

Secondary outcomes

  1. change of the Sleep Disturbance Scale for Children (SDSC).

    Time frame: baseline, 1 month, 3 months post transplantation

    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.

  2. change of the Gastrointestinal Symptom Rating Scale (GSRS) .

    Time frame: baseline, 1 month, 3 months post transplantation

    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.

  3. the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome.

    Time frame: baseline, 1 month, 3 months post transplantation

    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.

  4. intestinal barrier

    Time frame: baseline, 1 month, 3 months post transplantation

    plasma DAO, D-lactic acid and bacterial endotoxin levels

  5. change of Swanson, Nolan and Pelham-IV (SNAP-IV).

    Time frame: baseline, 1 month, 3 months post transplantation

    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).

  6. Conners' Parent Rating Scale-Revised

    Time frame: baseline, 1 month, 3 months post transplantation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, PhD

CONTACT

[email protected]

086-25-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Nanjing Medical University

Registry information

Official study title

Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.