Multi-strain Probiotics for ADHD

Last updated: January 23, 2024
Sponsor: Tsyr-Huey Mental Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

multiple-strain probiotics

Clinical Study ID

NCT06226584
MultiProbioADHD
  • Ages 8-11
  • All Genders

Study Summary

Probiotics are widely used as supplement for various neurodevelopmental disorders. The mechanism of their therapeutic potential lies in the "gut-brain axis", a two-way communication pathway through the neuroendocrine system. In the past, there have been many experiments to study the possible efficacy of probiotics in patients with ADHD. Although some studies have shown that probiotics can improve ADHD symptoms, most studies have used behavioral rating scales to evaluate. As a result, it is susceptible to informant bias. Standardized attentional tests and quantitative electroencephalogram (qEEG) can provide more objective data and detect possible changes in brain networks. Such changes may precede behavioral phenotypes. Therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qEEG).

Eligibility Criteria

Inclusion

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 accordingto DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattentionand/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' andteachers' observation)
  2. On stable psychotropic mediations (i.e. no change in dose of methylphenidate orantipsychotics) for past 8 weeks

Exclusion

Exclusion Criteria: Any patient meeting any of the exclusion criteria will be excluded from studyparticipation:

  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 geneticdiseases.
  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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: multiple-strain probiotics
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Tsyr-HueyMentalHospital

    Kaohsiung, 831
    Taiwan

    Active - Recruiting

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