Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

Phase 1

Recruiting

• Conditions: Attention-deficit/Hyperactivity Disorder
• Interventions: Drug: washed microbiota transplantation

• Registration Number: NCT06376331
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Study Start: 2024-04-28
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-05
• Primary Completion: 2027-06-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition;
2. Aged 3-17;
3. Received stable treatments for ≥1 month preceding 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. Unable to tolerate colonoscopy or anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Washed microbiota transplantation	washed microbiota transplantation	WMT

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Improvement (CGI-I)	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 Outcome Measures

Name	Time	Method
change of the Sleep Disturbance Scale for Children (SDSC).	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.
change of the Gastrointestinal Symptom Rating Scale (GSRS) .	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.
the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome.	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.
intestinal barrier	baseline, 1 month, 3 months post transplantation	plasma DAO, D-lactic acid and bacterial endotoxin levels
change of Swanson, Nolan and Pelham-IV (SNAP-IV).	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).
Conners' Parent Rating Scale-Revised	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.

Trial Locations

Locations (2)

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

SIR RUN RUN hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China