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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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).
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).
Glac Biotech Co., Ltd
Tainan, Taiwan
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.
Time frame: 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.
Time frame: 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.
Time frame: At 12th week.
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.
Time frame: At day 0 and 12th week.
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.
Time frame: At day 0 and 12th week.
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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.
Time frame: At day 0 and 12th week.
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.
Time frame: At day 0 and 12th week.
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. \[(Sleep efficiency = The length of the sleep period/The total sleep time on the bed)\*100%\]
Time frame: At day 0 and 12th week.
Cerebral blood flow
Using single photon emission computed tomography (SPECT/CT) to evaluate the changes in cerebral blood flow before and after probiotic intervention.
Time frame: At day 0 and 12th week.
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.
Time frame: At day 0 and 12th week.
Fecal flora
Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora before and after probiotic intervention.
Time frame: At day 0 and 12th week.