Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder

NCT06376331 | Recruiting Phase 1

• 1 other identifier: ADHD20240403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

attention-deficit/hyperactivity disorder; washed microbiota transplantation; fecal microbiota transplantation; sleep disturbance; gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions-Improvement (CGI-I)

  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.

  1 month, 3 months post transplantation

Secondary Outcomes (6)

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

  baseline, 1 month, 3 months post transplantation

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

  baseline, 1 month, 3 months post transplantation

• 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

• intestinal barrier

  baseline, 1 month, 3 months post transplantation

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

  baseline, 1 month, 3 months post transplantation

Study Arms (1)

Washed microbiota transplantation

EXPERIMENTAL

WMT

Drug: washed microbiota transplantation

Interventions

washed microbiota transplantation DRUG

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

Also known as: fecal microbiota transplantation

Washed microbiota transplantation

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Nanjing Medical University: collaborator

Study Sites (2)

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

Nanjing, Jiangsu, China

RECRUITING

SIR RUN RUN hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (14)

• 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.

  PMID: 38388701 BACKGROUND

• 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.

  PMID: 37474723 BACKGROUND

• 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.

  PMID: 37657199 BACKGROUND

• 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.

  PMID: 37149075 BACKGROUND

• 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.

  PMID: 37166201 BACKGROUND

• Tengeler AC, Dam SA, Wiesmann M, Naaijen J, van Bodegom M, Belzer C, Dederen PJ, Verweij V, Franke B, Kozicz T, Arias Vasquez A, Kiliaan AJ. Gut microbiota from persons with attention-deficit/hyperactivity disorder affects the brain in mice. Microbiome. 2020 Apr 1;8(1):44. doi: 10.1186/s40168-020-00816-x.

  PMID: 32238191 BACKGROUND

• Elhossiny RM, Elshahawy HH, Mohamed HM, Abdelmageed RI. Assessment of probiotic strain Lactobacillus acidophilus LB supplementation as adjunctive management of attention-deficit hyperactivity disorder in children and adolescents: a randomized controlled clinical trial. BMC Psychiatry. 2023 Nov 9;23(1):823. doi: 10.1186/s12888-023-05324-4.

  PMID: 37946220 BACKGROUND

• Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.

  PMID: 31919742 BACKGROUND

• Nanjing consensus on methodology of washed microbiota transplantation. Chin Med J (Engl). 2020 Oct 5;133(19):2330-2332. doi: 10.1097/CM9.0000000000000954. No abstract available.

  PMID: 32701590 BACKGROUND

• Bussing R, Fernandez M, Harwood M, Wei Hou, Garvan CW, Eyberg SM, Swanson JM. Parent and teacher SNAP-IV ratings of attention deficit hyperactivity disorder symptoms: psychometric properties and normative ratings from a school district sample. Assessment. 2008 Sep;15(3):317-28. doi: 10.1177/1073191107313888. Epub 2008 Feb 29.

  PMID: 18310593 BACKGROUND

• Goyette CH, Conners CK, Ulrich RF. Normative data on revised Conners Parent and Teacher Rating Scales. J Abnorm Child Psychol. 1978 Jun;6(2):221-36. doi: 10.1007/BF00919127.

  PMID: 670589 BACKGROUND

• Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996 Dec;5(4):251-61. doi: 10.1111/j.1365-2869.1996.00251.x.

  PMID: 9065877 BACKGROUND

• Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.

  PMID: 3123181 BACKGROUND

• Hooi SL, Dwiyanto J, Rasiti H, Toh KY, Wong RKM, Lee JWJ. A case report of improvement on ADHD symptoms after fecal microbiota transplantation with gut microbiome profiling pre- and post-procedure. Curr Med Res Opin. 2022 Nov;38(11):1977-1982. doi: 10.1080/03007995.2022.2129232. Epub 2022 Oct 7.

  PMID: 36164761 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 28, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)