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

Not Applicable

• Conditions: Mild cognitive impairment (MCI)

• Registration Number: JPRN-UMIN000031507
• Lead Sponsor: Juntendo Tokyo Koto Geriatric Medical Center Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)