AzTrials
AzTrials

Alzheimer DiseaseNCT05145881

Effect of Probiotics in Alzheimer's Disease

A study testing Low dose probiotics and Normal dose probiotics in people with Alzheimer Disease, run by Hsieh-Hsun Ho 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

In this clinical trial, five strains of probiotics (Bifidobacterium breve Bv-889, B. longum subspecies infantis BLI-02, B. bifidum VDD088, B. animalis subsp. lactis CP-9, Lactobacillus plantarum PL-02) with anti-oxidant and anti-inflammatory functions will been applied to slow down the development of the Alzheimer's… Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Low dose probiotics and Normal dose probiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTaiwan
Study dates
2 Apr 2020to 20 Jun 2023
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 50 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is between 50-95 years old.
  • The subject is clinically diagnosed with Alzheimer's disease, and it meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDB) or National Institute on Aging and Alzheimer's Association (NIAAA).
  • The subject's MMSE score is between 10-25.
  • The subject's CDR score is 0.5, 1, or 2.
  • The subject can cooperate to perform cognitive function tests.
  • The subject who have dependable caregivers who can record the compliance of taking probiotics and any physical conditions.
  • The subject or family members have signed the informed consent form.

Who cannot join

  • The subject is shown to have cerebrovascular disease by computer tomography.
  • The subject has dementia caused by other reasons, such as brain trauma, tumor, infection, epilepsy, etc.
  • The subject has used immunosuppressant drugs, steroids, T cell inhibitor ointments or received chemotherapy within 2 weeks.
  • The subject has consumed probiotic-related products (probiotic powder, yogurt or other fermented foods) within the past 1 month.
  • The subject has participated in clinical trials of other dementia medications in the past 1 month.
  • The subject is assessed for dementia caused by vitamin B12 deficiency or thyroid abnormalities.
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  • The subject suffers from mental illness, severe depression, schizophrenia, drug addiction, and alcohol addiction.
  • The subject has Parkinson's disease.
  • The subject is assessed to have severe metabolic dysfunction, liver and kidney dysfunction.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Glac Biotech Co., Ltd

    Tainan, 802

Other trials in Taiwan

About this study

Official title: Evaluation of Clinical Effect of Probiotics in Alzheimer's Disease: a Randomized, Double-blind Clinical Trial

In this clinical trial, five strains of probiotics (Bifidobacterium breve Bv-889, B. longum subspecies infantis BLI-02, B. bifidum VDD088, B. animalis subsp. lactis CP-9, Lactobacillus plantarum PL-02) with anti-oxidant and anti-inflammatory functions will been applied to slow down the development of the Alzheimer's disease through regulating the intestinal flora and immune system of patients with mild to moderate Alzheimer's disease symptoms. The efficacy of probiotic treatment against Alzheimer's disease will be evaluated.

Read the detailed description

Alzheimer's disease is a neurodegenerative disease that mainly results in dementia. According to statistics, about 60-70% of dementia patients in Taiwan are Alzheimer's patients. Currently, there is no effective medical treatments for Alzheimer's disease. Several drugs and psychotherapy have been developed to attenuate the symptoms of the disease. The initial symptoms of Alzheimer's disease are memory loss of recent events (short-term memory impairment) and the disease can eventually deprive the patient's self-awareness in the late phase. The main factor leading to Alzheimer's disease is rapid apoptosis of neuronal cells in the brain.

The neuronal apoptosis is mainly due to abnormal chronic inflammatory reactions and oxidative stress. The gut microbiota-brain axis (GMBA) reflects the two-way communication between the central nervous system (CNS) and the gastrointestinal tract. It has been reported that GMBA dysregulation is closely related to neurodegenerative diseases.

Elmira Akbari et al showed that patients with Alzheimer's disease supplemented with both Bifidobacterium and Lactobacillus for 12 weeks expressed significantly higher Mini-Mental State Examination (MMSE) scores than placebo group. Remarkably, biochemical indicators in the patient's serum, such as C-reactive protein and triglyceride were also improved significantly. However, the clinical study of Elmira Akbari did not further explore the role of Bifidobacterium in controlling Alzheimer's disease.

In this clinical trial, patients will be randomly divided into 2 groups: low dose probiotics and normal dose probiotics. All patients will be supplemented with the probiotics for 12 weeks. Their (1) cognitive function, (2) cognitive behavioral ability, (3) sleep status (4) cerebral blood flow (5) blood immune variation spectrum and blood biochemical indicators and (6) variation of fecal flora will be analyze. The therapeutic efficiency of the probiotics will be further evaluated by comparing the changes in data before and after probiotic treatment.

Being tested
Low dose probiotics, Normal dose probiotics
Keywords
Alzheimer's disease, Intestinal flora, Probiotics, Gut microbiota-brain axis (GMBA)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose probioticsDietary supplement

    Taking 1 package of low dose probiotic powder (B. breve Bv-889, B. longum subsp. infantis BLI-02, B. bifidum VDD088, B. animalis subsp. lactis CP-9, Lactobacillus plantarum PL-02) twice daily before meals (BIDAC).

  • Normal dose probioticsDietary supplement

    Taking 1 package of normal dose probiotic powder (B. breve Bv-889, B. longum subsp. infantis BLI-02, B. bifidum VDD088, B. animalis subsp. lactis CP-9, Lactobacillus plantarum PL-02) twice daily before meals (BIDAC).

Study groups in NCT05145881
Study groupRoleWhat they receive
Low dose probioticsActive comparatorNot described
Receives: Dietary Supplement: Low dose probiotics
Normal dose probioticsExperimentalNot described
Receives: Dietary Supplement: Normal dose probiotics

What is being measured

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

  1. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG)

    The minimum score is 0 and the maximum score is 70. A higher score means more severe cognitive impairment. The change in score before and after probiotic intervention will be evaluated.

    Measured: At day 0 and 12th week.

  2. Clinician's Interview-Based Impression of Severity (CIBIS)

    The minimum score is 1 and the maximum score is 7. A higher score means more severe mental illness. The change in score before and after probiotic intervention will be evaluated.

    Measured: At day 0.

  3. Clinician's Interview-Based Impression of Severity--plus caregiver input (CIBIS-plus)

    The minimum score is 1 and the maximum score is 7. A higher score means more severe mental illness. The change in score before and after probiotic intervention will be evaluated.

    Measured: At 12th week.

Secondary outcomes (8)

  1. Cognitive behavioral ability

    Evaluating the score difference of the following 3 indicators before and after probiotic intervention:

    1. Mini-Mental State Examination (MMSE). The minimum score is 0 and the maximum score is 30. A higher score means better cognitive function.
    2. Clinical Dementia Rating (CDR). The minimum score is 0 and the maximum score is 3. A higher score means more severe dementia.
    3. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL). The minimum score is 0 and the maximum score is 54. A higher score means better activities of daily living.

    Measured: At day 0 and 12th week.

  2. The length of the sleep period

    Wrist activity monitors will be used to record the length of the sleep period (hours) before and after the probiotic intervention.

    Measured: At day 0 and 12th week.

  3. The length of wake up after falling asleep

    Wrist activity monitors will be used to record the length of wake up (hours) after falling asleep before and after the probiotic intervention.

    Measured: At day 0 and 12th week.

  4. The total sleep time on the bed

    Wrist activity monitors will be used to record the total sleep time (hours) on the bed before and after the probiotic intervention.

    Measured: At day 0 and 12th week.

  5. Sleep efficiency

    Calculating sleep efficiency based on the length of the sleep period and the total sleep time on the bed recorded by Wrist activity monitors. [(Sleep efficiency = The length of the sleep period/The total sleep time on the bed)*100%]

    Measured: At day 0 and 12th week.

  6. Cerebral blood flow

    Using single photon emission computed tomography (SPECT/CT) to evaluate the changes in cerebral blood flow before and after probiotic intervention.

    Measured: At day 0 and 12th week.

  7. Blood immune variation spectrum and blood biochemical indicators.

    1. Detecting the changes of concentration in blood biochemical indexes, oxidative stress and cytokines before and after probiotic intervention.
    2. Detecting the changes of blood RNA level in the immune profile of IgG and IgA before and after the intervention of probiotics.

    Measured: At day 0 and 12th week.

  8. Fecal flora

    Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora before and after probiotic intervention.

    Measured: At day 0 and 12th week.

Timeline

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

  1. First posted6 Dec 2021
  2. Study start2 Apr 2020
  3. Primary completion20 Jun 2023
  4. Study completion20 Jun 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145881
Sponsor's protocol ID
ECKIRB1080701
Status last verified
Mar 2025
First submitted
11 Nov 2021
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low dose probiotics and Normal dose probiotics in people with Alzheimer Disease, run by Hsieh-Hsun Ho 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 7 inclusion and 9 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 18 Mar 2025. 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?

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?

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-COG) (time frame: At day 0 and 12th week.). 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?

On the ClinicalTrials.gov record for NCT05145881.

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 18 Mar 2025.

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