Attention Deficit and Hyperactivity DisordersNCT06226584
Multi-strain Probiotics for ADHD
A study testing multiple-strain probiotics in people with Attention Deficit and Hyperactivity Disorders, run by Tsyr-Huey Mental Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Attention Deficit and Hyperactivity Disorders
- What is being tested?
- multiple-strain probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A patient is eligible for the study if all of the followings apply:
- 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)
- On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks
Who cannot join
- Any patient meeting any of the exclusion criteria will be excluded from study participation:
- Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
- Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
- Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
- Participated in other clinical research in the past month.
- Vegetarians or those currently undergoing special diet therapy.
- Evaluation by the pediatric psychiatrist not suitable for entering the test
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tsyr-HueyMentalHospital
Kaohsiung City, 831
YU-SHIAN CHENG, MDPhD, 00886987173901, n043283@gmail.com
YU-SHIAN CHENG, MDPhD
About this study
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
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).
- Being tested
- multiple-strain probiotics
- Keywords
- ADHD, probiotics, quantitative electroencephalogram
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple-strain probioticsDietary supplement
Juice HA capsule which contains more than one strain of probiotics
| Study group | Role | What they receive |
|---|---|---|
| multiple-strain probiotics | Experimental | Not described Receives: Dietary Supplement: multiple-strain probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Swanson, Nolan and Pelham Chinese (SNAP) rating scales
for behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome
Measured: every one month for 3 months
Conners' Continuous Performance Test 3rd Edition
a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older
Measured: pre- and post-intervention (3 months)
quantitative electroencephalogram
measurement of brain wave patterns and coherence
Measured: pre- and post-intervention (3 months)
Secondary outcomes (1)
adverse events
any adverse events occurred during study
Measured: every one month for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start3 Jan 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit and Hyperactivity DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsyr-Huey Mental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Yu-Shian, Tsyr-Huey Mental Hospital
- Investigators
- YU-SHIAN CHENG, MDPhD, Principal investigator, Tsyr-Huey Mental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226584
- Sponsor's protocol ID
- MultiProbioADHD
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06226584
- Acronym / sponsor ID
- MultiProbioADHD
- Keywords
- ADHD, probiotics, quantitative electroencephalogram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tsyr-Huey Mental HospitalUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiple-strain probiotics | Experimental | Dietary Supplement: multiple-strain probiotics |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
- On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks
Key exclusion criteria (7 listed)
- Any patient meeting any of the exclusion criteria will be excluded from study participation:
- Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
- Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
- Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
- Participated in other clinical research in the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiple-strain probioticsJuice HA capsule which contains more than one strain of probiotics | Dietary supplement | multiple-strain probiotics |
Primary outcome
The Swanson, Nolan and Pelham Chinese (SNAP) rating scales
Time frame: every one month for 3 months
for behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome
Conners' Continuous Performance Test 3rd Edition
Time frame: pre- and post-intervention (3 months)
a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older
quantitative electroencephalogram
Time frame: pre- and post-intervention (3 months)
measurement of brain wave patterns and coherence
1 secondary outcome
adverse events
Time frame: every one month for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU-SHIAN CHENG, MDPhD principal investigator
Tsyr-Huey Mental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiple-strain probiotics in people with Attention Deficit and Hyperactivity Disorders, run by Tsyr-Huey Mental Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YU-SHIAN CHENG, MDPhD (00886978173901, n043283@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Swanson, Nolan and Pelham Chinese (SNAP) rating scales (time frame: every one month for 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.