Evaluation of the Effect of Wismemo on Alzheimer's Dementia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-02-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The present studies demonstrated that pro-inﬂammation, systemic oxidative stress and dysfunction in the brain-gut microbiota axis were involved in Alzheimer's disease (AD) pathogenesis. These results implied the decreased regulation of inflammation-associated risk and microbiota in AD patients could provide the novel strategies for combating the disease. This study was designed to assess the addition of Wismemo in treatment of cholinesterase inhibitors (such as donepezil, rivastigmine, galantamine) in the AD patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

NCT04100889

Alzheimer Disease Alzheimer Disease 1 Alzheimer Disease 2 +20 more

WITHDRAWN

Intervention of Intestinal Microorganism in Mild Cognitive Impairment

NCT03991195

Gut Microbiota Mild Cognitive Impairment Dementia, Alzheimer Type +1 more

COMPLETED NA

Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?

NCT05943925

Dementia Alzheimers Dementia With Lewy Bodies Parkinson Disease Dementia +2 more

UNKNOWN

Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease

NCT06920212

Fecal Microbiota Transplantation

ACTIVE_NOT_RECRUITING NA

Gut Microbiota and Alzheimer's Diseases

NCT03827733

Alzheimer Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Previously studies have shown some probiotics could improve stress-related diseases such as anxiety, autism, depression and schizophrenia might be through regulating brain-gut microbiota axis, pro-inﬂammation and oxidative stress. Although recent clinical study indicated that mix-probiotics (containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacteria bifidum and Lactobacillus fermentum) consumption could improve the cognitive function of dementia patients.

In this clinical study, whether Genmont specific strain probiotics could improve the clinical syndromes and delay worsens in Alzheimer's dementia patients with regular treatment were clarified. A Randomized, double-blind, placebo-controlled clinical trial would be carried out. AD's patients with regular treatment are additive consumption multi-strain probiotic supplement (Wismemo). Half of participants will receive Wismeno and regular treatment in combination, while the other half will receive placebo and regular treatment in combination. To evaluate of the effect of probiotic supplementation on cognitive, emotional and related status on Alzheimer's dementia patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Subjects received two placebo sachets per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Probiotic

Subjects received two Wismemo sachets with 1x10\^10 cfu/day

Group Type EXPERIMENTAL

Wismemo

Intervention Type DIETARY_SUPPLEMENT

Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wismemo

Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Regular treatment with Wismemo Regular treatment with placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects with Alzheimer's Dementia. (According to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association diagnostic criteria (NINCDS-ADRDA) and new criteria and guidelines to diagnose Alzheimer's disease were published in 2011 by the National Institute on Aging and Alzheimer's Association)
2. Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
3. Subjects in age of 55-95 years old.

Exclusion Criteria

1. Subjects are mixed dementia and vascular dementia.
2. Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
3. Participation in other clinical trials.
4. Subjects with thyroid dysfunction.
5. Subjects are receiving cancer drugs.
6. Subjects are receiving immunosuppressant drugs.

Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No