UMIN-CTR Clinical Trial

Public title

A Singlecenter, Randomized Controlled Trial of Bifidobacterium breve strain A1 in Patients with Mild Cognitive Impairment

Acronym

Trial of Bifidobacterium breve strain A1 in Patients with Mild Cognitive Impairment

Scientific Title

A Singlecenter, Randomized Controlled Trial of Bifidobacterium breve strain A1 in Patients with Mild Cognitive Impairment

Scientific Title:Acronym

Trial of Bifidobacterium breve strain A1 in Patients with Mild Cognitive Impairment

Region

Japan

Condition

Mild cognitive impairment (MCI)

Classification by specialty

Gastroenterology

Psychosomatic Internal Medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It is reported that oxidation stress and chronic neurologic inflammation participate in neurodegenerative abnormality of the central nervous system including Alzheimers dementia. It takes it more than ten years until tau protein begins to accumulate after Abeta began to accumulate in brain for Alzheimers dementia, and it becomes clear that a change is up in the brain since before having developed in Alzheimers dementia. If we are treated with the MCI of the stage before dementia and intervene, we may delay the onset of dementia.
On the other hand, it is reported that probiotics affects the central nervous system. In late years, in an animal study, the cognitive function improvement action of Alzheimers disease with the Bifidobacterium breve strain A1 dosage is reported. By the experiment that evaluated improvement action of Bifidobacterium breve strain A1 for the learning disability in the Abeta25-35 intracerebroventricular administration mouse using Y maze examination and a passive evasion examination, in the Bifidobacterium breve strain A1 administrated group, meaningful improvement was recognized in comparison with a control group in the spontaneous action change rate by the Y maze examination and the reaction latency by the passive evasion examination. This effect was at the same level as donepezil of the positive control, and an improvement effect to cognitive impairment by Bifidobacterium breve strain A1 was accepted. In addition, the cognitive function improvement effect by the probiotic intakes such as bifidus bacilli was reported in Alzheimer's dementia patients in the Homo sapiens. Therefore, in this study, we are intended that we perform the examination for the cognitive function improvement effect by the Bifidobacterium breve strain A1 intake for MCI patients by a randomized double-blind placebo-controlled study.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

To evaluate the efficacy of Bifidobacterium breve A1 with respect to the cognitive function measured by ADAS-Jcog in patients with MCI(mild cognitive impairment)

Key secondary outcomes

To evaluate the efficacy of Bifidobacterium breve A1 with respect to the cognitive function measured by MMSE, Vitality Index(VI), intestinal bacterial flora, FSSG questionnaire, Izumo scale, constipation scoring system(CSS)and brain MRI(VSRAD) in patients with MCI(mild cognitive impairment)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Investigational Treatment: Bifidobacterium breve A1 o.d. p.o. 24 weeks

Interventions/Control_2

Comparative treatment: Placebo o.d. p.o. 24 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Age between 65-89 (inclusive)

2) Patients with MCI who satisfy the clinical criteria of MCI(DSM-5) and who also satisfy the following three criteria:
i) Memory complaint by subject or family
ii) Mini-Mental State Examination (MMSE) scores between 22 and 26 (inclusive)
iii) Clinical Dementia Rating (CDR) = 0.5

3) Written informed consent provided for study participation

Key exclusion criteria

1) Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, epilepsy, multiple sclerosis, cerebral infection, or subsequent complication caused by head trauma. History of major depre ssion or bipolar disorder, alcohol or other substance abuse. Findings of multi ple infarction, braintumor or subdural hematoma. Cognitive impairment d ue to deficiency of vitamin B12 or folate. Neurosyphilis. Thyroid functio n abnormality.

2) Severe disease(cerebro-vascular, heart, liver, renal , gastro-intestinal, endocrine-metabolic, infectious disease). Cancer of the alimentary system. After gastrointestinal tract resection. Inflammatory bowel disease(IBD).

3) Users for pharmaceutical products affecting the bowel movement regularly(antibiotic, medicine for intestinal disorders, laxative, antidiarrheic) and health food, supplement (lactic acid bacterium, bifidus bacillus, oligosaccharide, dietary fiber)

4) remarkable abnormality for blood pressure, blood test. Severe anemia. Allergy for drug and food. Heavy smoker, drinker. Irregular lifestyle such as a meal, the sleep.

5) Users for Anti-dementia drugs, Psychoactive drugs, Severe diabetes melitus treated with insulin.

6) Contraindications f or MRI such as magnetic body or metal.

7) Participation in any other new drug study for Alzheimer's disease. Participation in another new drug study.

8) Considered by the principal investigator to be ineligible.

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Asaoka

Organization

Juntendo Tokyo Koto Geriatric Medical Center

Division name

Department of Gastroenterology

Zip code

Address

3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan

TEL

+81-3-5632-3111

Email

daisuke@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Asaoka

Organization

Juntendo Tokyo Koto Geriatric Medical Center

Division name

Department of Gastroenterology

Zip code

Address

3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan

TEL

+81-3-5632-3111

Homepage URL

Email

daisuke@juntendo.ac.jp

Institute

Juntendo Tokyo Koto Geriatric Medical Center
Department of Gastroenterology

Institute

Department

Personal name

Organization

University of Juntendo, intestinal flora research course

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂東京江東高齢者医療センター

Date of disclosure of the study information

2018

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

28

Day

Last modified on

2018

Year

02

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035970