Search / Trial NCT06226584

Multi-strain Probiotics for ADHD

Launched by TSYR-HUEY MENTAL HOSPITAL · Jan 23, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Adhd Probiotics Quantitative Electroencephalogram

ClinConnect Summary

This clinical trial is studying the effects of multi-strain probiotics on children with Attention Deficit Hyperactivity Disorder (ADHD). Probiotics are beneficial bacteria that can help improve gut health, and researchers believe they might also help with ADHD symptoms by influencing the brain-gut connection. The trial aims to provide more objective evidence of the probiotics’ effectiveness by using standardized attention tests and brain wave measurements instead of just relying on parent and teacher behavior ratings.

To participate, children aged 8 to 11 who have been diagnosed with ADHD by a qualified doctor may be eligible, as long as they have been on a stable dose of ADHD medication for at least eight weeks. However, children with serious mental or physical health issues, those who have taken antibiotics or probiotics recently, or those on special diets will not be included. If your child qualifies and joins the study, they can expect to undergo tests that assess their attention and brain activity to help researchers understand how probiotics might affect their ADHD symptoms.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • A patient is eligible for the study if all of the followings apply:
  • 1. 8-11 children diagnosed with ADHD by board certified pediatric psychiatrist according to DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation)
  • 2. On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks
  • Exclusion Criteria:
  • Any patient meeting any of the exclusion criteria will be excluded from study participation:
  • 1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
  • 2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
  • 3. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
  • 4. Participated in other clinical research in the past month.
  • 5. Vegetarians or those currently undergoing special diet therapy.
  • 6. Evaluation by the pediatric psychiatrist not suitable for entering the test

Trial Officials

YU-SHIAN CHENG, MDPhD

Principal Investigator

Tsyr-Huey Mental Hospital

About Tsyr Huey Mental Hospital

Tsyr-Huey Mental Hospital is a leading clinical research facility dedicated to advancing mental health care through innovative research and therapeutic interventions. With a commitment to ethical standards and patient-centered approaches, the hospital conducts rigorous clinical trials aimed at evaluating the efficacy and safety of novel treatments for various psychiatric disorders. Its multidisciplinary team of experienced clinicians, researchers, and mental health professionals collaborates to foster a supportive environment for participants, ensuring comprehensive care and oversight throughout the research process. Tsyr-Huey Mental Hospital strives to contribute to the body of knowledge in mental health, ultimately enhancing treatment options and outcomes for patients worldwide.

Locations

Kaohsiung, , Taiwan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0