Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder
ID: NCT06376331
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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.
Read Full Scientific Objectives & Methods
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.
The prepared microbiota suspension was infused into the participates' lower gut.
Treatment Arms Description
WMT
- 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.
- 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
Primary Outcome Measures
- 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.
View Secondary Outcome Measures (6)
- 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.
- 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.
- 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.
- intestinal barrier — Time Frame: 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). — 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).
- 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.
This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 2 Facilities & Contact Sites
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- Faraone SV, Bellgrove MA, Brikell I, Cortese S, Hartman CA, Hollis C, Newcorn JH, Philipsen A, Polanczyk GV, Rubia K, Sibley MH, Buitelaar JK. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers. 2024 Feb 22;10(1):11. doi: 10.1038/s41572-024-00495-0.PubMed ↗
- Bansal PS, Goh PK, Southward MW, Sizemore YJ, Martel MM. Impulsivity as key bridge symptoms in cross-sectional and longitudinal networks of ADHD and ODD. J Child Psychol Psychiatry. 2024 Jan;65(1):52-63. doi: 10.1111/jcpp.13863. Epub 2023 Jul 20.PubMed ↗
- Liang X, Qiu H, Li SX. Objectively measured sleep continuity in children and adolescents with ADHD: A systematic review and meta-analysis. Psychiatry Res. 2023 Oct;328:115447. doi: 10.1016/j.psychres.2023.115447. Epub 2023 Aug 28.PubMed ↗
- Hartman CA, Larsson H, Vos M, Bellato A, Libutzki B, Solberg BS, Chen Q, Du Rietz E, Mostert JC, Kittel-Schneider S, Cormand B, Ribases M, Klungsoyr K, Haavik J, Dalsgaard S, Cortese S, Faraone SV, Reif A. Anxiety, mood, and substance use disorders in adult men and women with and without attention-deficit/hyperactivity disorder: A substantive and methodological overview. Neurosci Biobehav Rev. 2023 Aug;151:105209. doi: 10.1016/j.neubiorev.2023.105209. Epub 2023 May 5.PubMed ↗
- Wang Q, Yang Q, Liu X. The microbiota-gut-brain axis and neurodevelopmental disorders. Protein Cell. 2023 Oct 25;14(10):762-775. doi: 10.1093/procel/pwad026.PubMed ↗
View Official Medical/Scientific Title
Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder and Its Comorbidities