Dynamic Response to Probiotics in Context of Alzheimer Disease: a Proof-of-concept Study

NCT05521477 | Completed

• 1 other identifier: 2022-01052
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

proof-of-concept study to adequately design a larger trial to investigate the effect of supplementation of a probiotic (SLAB51) on AD biomarker.

Conditions

Alzheimer Disease

Keywords

microbiome; alzheimer disease; probiotic

Outcome Measures

Primary Outcomes (3)

• Concentration of plasma AD biomarker, Amyloid

  The dynamic changes of plasma amyloid concentration, namely Ab40 and Ab42 in pg/ml, will be reported in the blood shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

  within a year of last participant finalising the study

• Concentration of plasma AD biomarker, Tau

  The dynamic changes of plasma Tau concentration more specifically p-Tau-181, p-Tau-231 and Tau in pg/ml, will be reported in the blood shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

  within a year of last participant finalising the study

• Concentration of plasma AD biomarker, Nfl

  The dynamic changes of plasma concentration neurofilament light (NfL in pg/ml), will be reported in the blood shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

  within a year of last participant finalising the study

Secondary Outcomes (5)

• Plasma concentration of GFAP

  within a year of last participant finalising the study

• Plasma concentration of a panel of cytokines

  within a year of last participant finalising the study

• Plasma concentration of VCAM and NCAM

  within a year of last participant finalising the study

• Profiling of gut bacterial population isolated from stools

  within a year of last participant finalising the study

• Plasma and stool concentration of bacterial derived metabolites

  within a year of last participant finalising the study

Study Arms (1)

participant procedure

EXPERIMENTAL

each participant will go through 3 phases of identical protocol. In each phases blood and stools will be collected at specific days, as well as cardiometabolic measures, transit time, cognitive tests and food consumption. Each phase last 2 weeks with a washout period of 1 month in between. In the first phase, no treatment will be provided, in the second phase a low dose of probiotic (once a day for five days) will be given and in the third phase high dose of probiotic (twice a day for five days) will be administered.

Dietary Supplement: SLAB51

Interventions

SLAB51 DIETARY_SUPPLEMENT

One dose of probiotic consists of a bag of probiotic powder to dissolve in a glass of water according to the manufacturer instructions. Each bag contains 100 billion bacteria of the following strains: streptococcus thermophilus DSM 32245, 2 Bifidobacteria lactis DSM 32246 and DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244 and Lactobacillus brevis DSM 27961.

Also known as: Agimixx

participant procedure

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of mild cognitive impairment (MCI) due to AD, obtained from the clinical path of the participant in the memory clinic according to the criteria of Petersen et al. 1999 (46)
• Previous evidence of brain amyloidosis (assessed by positron emission tomographie (PET) or cerebrospinal fluid (CSF))
• Carrier of APOEe4 gene allele
• Defecates at least once a day

You may not qualify if:

• Antibiotic consumption 1 month prior the intervention
• Prebiotic consumption 1 month prior the intervention
• Recent change in diet habit (eg: vegetarian, vegan, high protein diet)
• Current alcohol addiction
• Current smoking habit
• Clinical diagnosis of dementia.
• Contraindications to probiotic consumption
• Inability to undergo the procedures of the study, e.g., severe behavioural disturbances.
• severe diseases:
• Life threatening diseases,
• Severe systemic diseases (e.g., kidney insufficiency, cardiac insufficiency, decompensated diabetes, decompensated metabolic diseases, decompensated hypothyroidism, uncontrolled autoimmune diseases);
• Chronic digestive diseases (e.g.: Crohn's disease, Ulcerative colitis, C. difficile infection)
• Chronic immune diseases
• The participation to a clinical trial involving potential Alzheimer's disease modifying therapies.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University hospitals - Memory clinic

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Giovanni B Frisoni, MD

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Professor

Model Details: The study design will allow to evaluate the dose dependent effect of probiotic consumption on AD blood-based biomarker by comparing each individual to its baseline sampling. Each participant will follow a 3 phases program of identical procedures: * Phase I - baseline control: no probiotic will be consumed * Phase II - Low dose probiotic consumption: 1 dose of probiotic will be taken in the morning for 5 days * Phase III - High dose probiotic consumption: The subject will receive 1 dose of probiotic in the morning and one dose in the evening for 5 days In all phases (2 weeks time) blood, stools, cardiometabolic parameter, food frequency, cognitive, anxiety and depression assessment will be collected at specific time points (either shortly before, during or shortly after the treatment period).

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 30, 2022
• Study Start: September 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)