Cognitive improvement bifidobacteria intervention test JICIB test

JRCT ID: jRCTs041210166

Registered date:22/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 12/12/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Test food: A food containing 50 billion Bifidobacterium A1 sachets per test food or a placebo food: A food containing no bifidobacterium and containing 2000 mg of maltodextrin (both are manufactured by Morinaga Milk Co., Ltd.).
Take 1 bags/day for 48 weeks.

Outcome(s)

• Primary Outcome: Amount of change from baseline in ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) test from the time of registration as a neuropsychological test (at the end of the test: 48 weeks)

Secondary Outcome

1 Amount of change from baseline in the MMSE-J test from the time of registration as a neuropsychological test (at the end of the test: 48 weeks)
2 Behavioral Psychological Symptoms (BPSD) Evaluation (Amount of change from baseline in NPI-Q (Neuropsychiatric Inventory Questionnaire) from the time of enrollment (at the end of the study: 48 weeks))
3 Volumetric quantitative evaluation by MRI
4 Changes in general test items, surrogate markers, and metabolite profile from the initial test to the end of the test (48 weeks)
5 Changes from initial examination of intestinal flora and metabolite profile to end of study (48 weeks)
6 Evaluation of fecal properties by Bristol Scale

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) MMSE-J (Nippon Bunka Kagakusha) score is 10-26
(2) Persons who have entered a facility related to Fukushimura Hospital and are attending Fukushimura Hospital if they are 50 years of age or older at the time of obtaining consent.
(3) Persons who have been receiving medical treatment in the same environment for one month or more and are expected to receive medical treatment in the same environment in the future.
(4) A person who has a substitute (guarantor at the time of admission / admission) when it is difficult to obtain document consent from the person

Exclude criteria

(1) Those who have difficulty ingesting orally
(2) Persons with impaired consciousness
(3) Those who have difficulty going to Fukushimura Hospital
(4) Persons with hearing impairment that can affect psychological tests
(5) Persons with MMSE-J (Nippon Bunka Kagakusha) score of 9 points or less or 27 points or more
(6) When there are obvious lesions other than neurodegenerative diseases in the brain such as cerebrovascular accident, normal pressure hydrocephalus, subdural hematoma, and brain tumor by prior imaging examination
(7) Persons with physical complications that may affect the study
(8) Others who are judged to be inappropriate by the investigator

Related Information

• Primary Sponsor: Akatsu Hiroyasu
• Source(s) of Monetary Support: MORINAGA MILK INDUSTRY CO., LTD.