Clinical trial NCT06226584: Multi-strain Probiotics for ADHD
Official title: Therapeutic Effects of Multiple-strain Probiotics for Children With ADHD Based on Assessment of Standardized Attention Tests and Quantitative Electroencephalogram: a Single Arm Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit and Hyperactivity Disorders
Keywords: ADHD
probiotics
quantitative electroencephalogram
Lead sponsor: Tsyr-Huey Mental Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: The Swanson, Nolan and Pelham Chinese (SNAP) rating scales
timeFrame: every one month for 3 months
measure: Conners' Continuous Performance Test 3rd Edition
timeFrame: pre- and post-intervention (3 months)
measure: quantitative electroencephalogram
timeFrame: pre- and post-intervention (3 months)
Secondary outcomes:
measure: adverse events
timeFrame: every one month for 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Tsyr-HueyMentalHospital
Study officials:
affiliation: Tsyr-Huey Mental Hospital
name: YU-SHIAN CHENG, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: