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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031507

Enrollment

140

Registered

2018-03-01

Start date

2018-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment (MCI)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactDaisuke Asaoka

Juntendo Tokyo Koto Geriatric Medical Center Department of Gastroenterology

daisuke@juntendo.ac.jp+81-3-5632-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026