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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031507
Receipt No. R000035970
Scientific Title A Singlecenter, Randomized Controlled Trial of Bifidobacterium breve strain A1 in Patients with Mild Cognitive Impairment
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/28

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Basic information
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
Condition Mild cognitive impairment (MCI)
Classification by specialty
Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Juntendo Tokyo Koto Geriatric Medical Center
Department of Gastroenterology
Institute
Department

Funding Source
Organization University of Juntendo, intestinal flora research course
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂東京江東高齢者医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2018 Year 02 Month 28 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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