Effect of Probiotics in Alzheimer's Disease

NCT05145881 | Completed

• 1 other identifier: ECKIRB1080701
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; Intestinal flora; Probiotics; Gut microbiota-brain axis (GMBA)

Outcome Measures

Primary Outcomes (3)

• 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.

  At day 0 and 12th week.

• 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.

  At day 0.

• 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.

  At 12th week.

Secondary Outcomes (8)

• Cognitive behavioral ability

  At day 0 and 12th week.

• The length of the sleep period

  At day 0 and 12th week.

• The length of wake up after falling asleep

  At day 0 and 12th week.

• The total sleep time on the bed

  At day 0 and 12th week.

• Sleep efficiency

  At day 0 and 12th week.

Study Arms (2)

Low dose probiotics

ACTIVE COMPARATOR

Dietary Supplement: Low dose probiotics

Normal dose probiotics

EXPERIMENTAL

Dietary Supplement: Normal dose probiotics

Interventions

Low dose probiotics DIETARY_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).

Low dose probiotics

Normal dose probiotics DIETARY_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).

Normal dose probiotics

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hsieh-Hsun Ho: lead

Study Sites (1)

Glac Biotech Co., Ltd

Tainan, 802, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hsieh-Hsun Ho, Ph.D

  Glac Biotech Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: R&D Director

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 6, 2021
• Study Start: April 2, 2020
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

TW (1)