Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

NCT ID: NCT06948929

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2026-12-15

Brief Summary

In recent years, emerging studies have revealed the role of gut microbiota in human health and diseases, including AD and other neurodegenerative conditions5. Although the underlying mechanism is still largely unknown, successful therapies targeting the gut-brain axis may serve as indirect evidence of the possible linkage.

This pilot, single-arm study aims to estimate the efficacy and assess the safety profile of the use of a new synbiotic formula (SCV09) in improving dementia-related behaviour in Alzheimer's disease patients, paving the way for a large-scale randomised controlled trial in the future.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single arm intervention only

SV09

1 sachet daily for 6 months

Group Type: EXPERIMENTAL

SCV09

Intervention Type: DIETARY_SUPPLEMENT

SCV09 consists of a blend of four probiotic species from the Bifidobacterium and Lactobacillus genera (20 billion CFU in 1 sachet per day), prebiotic compounds including galacto-oligosaccharides, xylo-oligosaccharides and inulin, vitamin B6, B9, B12 and vitamin D.

Interventions

SCV09

SCV09 consists of a blend of four probiotic species from the Bifidobacterium and Lactobacillus genera (20 billion CFU in 1 sachet per day), prebiotic compounds including galacto-oligosaccharides, xylo-oligosaccharides and inulin, vitamin B6, B9, B12 and vitamin D.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Individuals aged between 60-85 with a clinical diagnosis of Alzheimer's disease
• Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score of ≤20
• Neuropsychiatric Inventory-Questionnaire (NPI-12) ≥10
• Stable medication history for Alzheimer's disease within the past 4 weeks
• Have been taken care by a responsible caregiver who could assist the patient in taking the study products, collecting stool samples and attending the clinical follow-up •-Able to provide informed consent

Exclusion Criteria

• Concomitant Parkinson's disease and other neurodegenerative conditions affecting activities of daily living
• History of stroke
• History of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
• Confirmed active malignancy
• Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months
• Use of anti-psychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months
• Inability to receive oral fluids
• Use of antibiotics, probiotics or prebiotics in the last 2 weeks
• Intolerance to probiotics or lactose

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Timothy Kwok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor Timothy Kwok

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinse University of Hong Kong

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Professor Timothy Kwok

Role: CONTACT

tkwok@cuhk.edu.hk

+852 35053145

Joanna Cheng, MSc

Role: CONTACT

chengoiyue@cuhk.edu.hk

+852 35053990

Facility Contacts

Professor Timothy Kwok

Role: primary

tkwok@cuhk.edu.hk

+852 35053145

Joanna Cheng, MSc

Role: backup

chengoiyue@cuhk.edu.hk

+852 35053990

Other Identifiers

2024.530

Identifier Type: -

Identifier Source: org_study_id