Multi-strain Probiotics for ADHD

T

Tsyr-Huey Mental Hospital

Status

Enrolling

Conditions

Attention Deficit and Hyperactivity Disorders

Treatments

Dietary Supplement: multiple-strain probiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT06226584
MultiProbioADHD

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

multiple-strain probiotics
Experimental group
Treatment:
Dietary Supplement: multiple-strain probiotics

Trial contacts and locations

1

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Central trial contact

YU-SHIAN CHENG, MDPhD

Data sourced from clinicaltrials.gov

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