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Efficacy and Safety Study Protocol for Fecal Microbiota Transplantation in Children with Attention Deficit Hyperactivity Disorder

Efficacy and Safety Study Protocol for Fecal Microbiota Transplantation in Children with Attention Deficit Hyperactivity Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092320
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

attention deficit hyperactivity disorder

Interventions

Conventional treatment group:Transcranial magnetic stimulation therapy
Fecal microbiota transplantation combined with conventional treatment group:Oral fecal microbiota transplantation capsule combined with transcranial magnetic stimulation therapy

Sponsors

Xijing Hospital, the Fourth Military Medical University, Xi'an, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1)Diagnosed by a treating physician or above, meeting the diagnostic criteria for ADHD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). (2)Ages 6-12 years old. (3)Intelligence tested using the Revised Wechsler Intelligence Scale for Children (C-WISC) Fourth Edition, with a total IQ =70. (4)No visual or auditory impairments, able to understand and respond to test tasks. (5)Not taking any central nervous system stimulants or other psychiatric medications. (6)Parental informed consent signed for children with ADHD.

Exclusion criteria

Exclusion criteria: (1)Age greater than 12 years or less than 6 years; (2)History of pervasive developmental disorders, tic disorders, organic brain diseases, neurological diseases, and severe mental illnesses; (3)History of organic brain diseases such as brain trauma, cerebral palsy, encephalitis, etc.; (4)History of severe organic diseases of the heart, liver, kidney, and major physical illnesses, as well as history of drug dependence; (5)History of organic intestinal diseases such as congenital megacolon, intestinal obstruction, and intussusception; (6)History of pathological inflammatory changes in the intestine such as inflammatory bowel disease; (7)History of severe obesity or severe malnutrition; (8)Use of probiotics and antibiotics that clearly affect the intestinal flora within 3 months before consultation or during treatment within 6 months; (9)Accompanied by other serious diseases that may affect their survival (including serious infections, serious heart, kidney, respiratory, hematological, endocrine diseases), or with tumors; (10)Inability to take fecal microbiota transplantation (FMT) pediatric capsules orally.

Design outcomes

Primary

MeasureTime frame
ADHD Rating Scale for Children Score;

Secondary

MeasureTime frame
Diversity of gut microbiota;Neurotransmitter concentrations in serum;Changes in urinary metabolomics;Brain functional imaging;

Countries

China

Contacts

Public ContactSun Xin

Xijing Hospital, the Fourth Military Medical University, Xi'an, China

xinsun001@qq.com+86 135 7253 6262

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026