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ADHDPhase 3NCT04958460

Effect of Probiotics on ADHD

A Phase 3 study testing BF688 in people with ADHD and Probiotics, run by Wang Liang-Jen at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators previously found the relative abundance of Sutterella stercoricanis were increased and Bifidobacterium bifidum were decreased in the ADHD… Read more about this study

Who is it for?
Ages 4 to 16 years
Conditions the study is for
ADHD, Probiotics, Gut Microbiota
What is being tested?
BF688
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteTaiwan
Study dates
14 May 2020to 28 Feb 2023
Phase
Phase 3
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 4 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ADHD

Who cannot join

  • Autism
  • MR
  • Developmental Delay
  • Vegetarian

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Liang-Jen Wang

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: Effect of Bifidobacterium Bifidum (Bf-688) on Clinical Characteristics and Gut Microbiota in Attention-deficit/Hyperactivity Disorder: a Double-blind Randomized-control Trial

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators previously found the relative abundance of Sutterella stercoricanis were increased and Bifidobacterium bifidum were decreased in the ADHD group. Investigators hypothesize that ADHD patients receiving supplementary Bifidobacterium bifidum (Bf-688) is able to increase the proportion of Bf-688; inhibit the proportion of Sutterella; and improve ADHD symptoms.

Read the detailed description

Aims:

Investigators will conduct an open-label, single arm study and a randomized, double-blind clinical trial to examine whether Bf-688 can achieve similar effects to therapeutic drugs for ADHD.

Methods:

The duration of this clinical trial is expected to be 2 years (March 2020 to February 2022).

  1. In the first stage of study, investigators will conduct an open-label, single arm study. Investigators will recruit 30 children aged 4-16 who are diagnosed as ADHD who are eligible to participate in the trial. The patients will be administrated with Bf-688, 1 pack each morning and evening (5×109 colony forming units (CFUs) per day) for 8 weeks. At the baseline, 2nd, 4th and 8th week, the clinical symptoms of ADHD will be evaluated using the SNAP-IV and ADHD-RS. At weeks 0 and 8, blood samples and fecal samples will be collected and psychological tests will be performed.
  2. In the second stage of study, This clinical trial is a prospective, randomized, double-blind, parallel-controlled clinical trial for children aged 6-12 years old who are diagnosis of ADHD and who are currently receiving ADHD drug therapy. A total of 120 patients will be recruited in this trial. All subjects will be randomly assigned (allocation ratio 1:1) to one of the following two groups (60 people in each group): (1) Probiotics group: The original ADHD drug will be continuously used, and the Bf-688 packet (5×109 CFUs) will be administrated in the morning and in the evening daily. (2) Placebo group: The original ADHD drug will be continuously used, and the placebo packet will be administrated in the morning and in the evening daily.

The patients will take the above prescription for 12 consecutive weeks. At the 0th, 4th, 8th, and 12th weeks, parents and teachers will be asked to fill SNAP-IV, and the researcher will use ADHD-RS to evaluate the clinical symptoms of ADHD. At the 0th week and 12th week, stool samples will be collected and psychological tests will be performed (CPT and CATA). Nucleic acid sequencing technology is used to identify bacterial species in feces, and high-throughput 16S rRNA sequences can be quickly obtained through Next Generation Sequencing (NGS), and fecal metabolites analysis.

Expected results:

Investigators expect to find that Bf-688 exhibit significant better effects than the placebo group for treating ADHD patients. This result will validate that gut microbiota modification may be beneficial for the behavioral symptoms of ADHD children, and the outcome may have the potential for patent and commercialization.

Being tested
Placebo, BF688
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.

  • PlaceboDrug

    Administrated 1 packet of maltodextrin (as placebo of Bf-688) in the morning and evening

  • BF688Other

    Administrated 1 pack each morning and evening (5×109 CFUs per day)

Study groups in NCT04958460
Study groupRoleWhat they receive
Probiotics groupExperimentalProbiotics Candidates conditions excluded: 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 that will affect the results of intestinal microflora assessment 3. Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month. 4. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 5. Participated in other clinical research in the past month. 6. Vegetarians or those currently undergoing special diet therapy. 7. Evaluation by the host is not suitable for entering the test.
Receives: Other: BF688
Control groupPlacebo comparatorPlacebo Candidates conditions excluded: 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 that will affect the results of intestinal microflora assessment 3. Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month. 4. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 5. Participated in other clinical research in the past month. 6. Vegetarians or those currently undergoing special diet therapy. 7. Evaluation by the host is not suitable for entering the test.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E)

    screening

    Measured: At the baseline

  2. The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    Measured: At the baseline

  3. The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    Measured: 2nd week

  4. The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    Measured: 4th week

  5. The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start14 May 2020
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958460
Sponsor's protocol ID
201901479A3C601
Status last verified
Apr 2023
First submitted
23 Apr 2021
Last updated
6 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BF688 in people with ADHD and Probiotics, run by Wang Liang-Jen 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 6 Apr 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E) (time frame: At the baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04958460.

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 6 Apr 2023.

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