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A randomized, double-blind, placebo-controlled parallel trial of Probio-M8 as an adjuvant treatment for Alzheimer

A randomized, double-blind, placebo-controlled parallel trial of Probio-M8 as an adjuvant treatment for Alzheimer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091801
Enrollment
Unknown
Registered
2024-11-04
Start date
2024-11-05
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Alzheimer's disease

Interventions

Experimental group:Administration of Bifidobacterium animalis subsp. lactis Probio-M8 combined drug (access to standardised treatment), once daily, one bag at a time for 3 months.
control group:Administration of a placebo without Bifidobacterium animalis subsp. lactis Probio-M8 combined drug (access to standardised treatment), once daily, one bag at a time for 3 months.

Sponsors

Affiliated Hospital of Inner Mongolia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age range is 50-80 years old; 3. No gender restrictions; 4. Clinical diagnosis of AD and no other psychiatric disorders; MMSE scores between 10-27 indicate mild to moderate cognitive impairment.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic to bacterial powder or its components; 2. Current or historical conditions of drug dependence, drug abuse, or alcohol poisoning; 3. Has serious visual, auditory, or motor impairments; 4. Have used antibiotics, probiotics, or synbiotics within the past month; 5. Conduct dietary and exercise therapy under the advice of a doctor; 6. Have a history of liver disease or severe kidney, endocrine, cardiovascular, gastrointestinal, lung, hematological, and metabolic diseases, or have received medication treatment for the aforementioned diseases; 7. History of major surgeries involving gastrectomy, gastrointestinal suture surgery, intestinal resection, and digestive system; 8. Participated in other clinical trials within the past month; Participants who are unwilling to provide personal information and do not wish to enter the study.

Design outcomes

Primary

MeasureTime frame
Score of the Simplified Intelligence Status Examination Scale;

Secondary

MeasureTime frame
Score of Activity of Daily Living Scale;Score of the Quality of life-Alzheimer‘s Disease;

Countries

China

Contacts

Public Contacthuangfu weizhong

Affiliated Hospital of Inner Mongolia Medical University

nmzzx13644875037@163.com+86 136 4487 5037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026