Viewing Study NCT06376331



Ignite Creation Date: 2024-05-06 @ 8:24 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06376331
Status: RECRUITING
Last Update Posted: 2024-04-24
First Post: 2024-04-16

Brief Title: Washed Microbiota Transplantation for Attention-deficitHyperactivity Disorder
Sponsor: The Second Hospital of Nanjing Medical University
Organization: The Second Hospital of Nanjing Medical University

Study Overview

Official Title: Washed Microbiota Transplantation for Attention-deficitHyperactivity Disorder and Its Comorbidities
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Attention-deficithyperactivity 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 Parkinsons 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None