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Alzheimer DiseaseHISTEPPANCT05521477

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

A study testing SLAB51 in people with Alzheimer Disease, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Alzheimer Disease
What is being tested?
SLAB51
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2022to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Geneva University hospitals - Memory clinic

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: HIgh Frequency Sampling to sTudy the Physiological Effect of Probiotics on Peripheral Markers of Alzheimer's Pathology: a Proof-of-concept Study

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

Read the detailed description

BACKGROUND: A growing body of evidence suggests an effect of gut bacteria and their metabolites on brain health, including the development of neurodegenerative conditions and Alzheimer's disease (AD). Probiotic supplementation is commonplace in medicine but targeting the gut microbiome to prevent AD is poorly understood and little is known on the dynamic effects of probiotics on physiology.

AIM: This is a proof-of-concept study to adequately design a larger trial to investigate the effect of supplementation of a probiotic (SLAB51) on AD biomarker. The study will use a high frequency sampling to closely monitor the physiological dynamics as the result of low and high dose consumption of the probiotic.

METHODS: Study subjects will be three patients with prodromal AD between 60 and 80 years old and carrying the apolipoprotein E (APOE) e4 allele. Participants will sequentially receive no supplement (run-in), low and high doses of probiotics for five consecutive days with a washout period in-between. Blood and stools will be collected every day or every second days. The main readout will be the established plasma markers of AD, and more exploratory analysis will be performed on putative mediators of the gut-brain axis.

EXPECTED OUTCOME: Curves of dynamic change of the readouts will be built for each subject, and a model of the response will be estimated. The results of this project will help design a larger trial to identify the most promising analytes showing a dynamic response to probiotic consumption and better understand the link to the pathology.

Being tested
SLAB51
Keywords
microbiome, alzheimer disease, probiotic
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLAB51Dietary supplement

    Also called Agimixx

    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.

Study groups in NCT05521477
Study groupRoleWhat they receive
participant procedureExperimentaleach 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.
Receives: Dietary Supplement: SLAB51

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within a year of last participant finalising the study

  2. 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.

    Measured: within a year of last participant finalising the study

  3. 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.

    Measured: within a year of last participant finalising the study

Secondary outcomes (5)

  1. Plasma concentration of GFAP

    The dynamic changes in concentration of plasma glial fibrillary acidic protein (GFAP), as a marker of neuroinflammation, will be reported shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

    Measured: within a year of last participant finalising the study

  2. Plasma concentration of a panel of cytokines

    The dynamic changes in concentraion of a large panel of cytokines measured in plasma, as markers of systemic inflammation, will be reported shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

    Measured: within a year of last participant finalising the study

  3. Plasma concentration of VCAM and NCAM

    The dynamic changes in concentration of plasma VCAM and NCAM, as markers of endothelial dysfunction, will be reported shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

    Measured: within a year of last participant finalising the study

  4. Profiling of gut bacterial population isolated from stools

    The dynamic changes in alpha and beta diversity, as well as the functionality of gut bacterial population isolated from stools will be reported shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

    Measured: within a year of last participant finalising the study

  5. Plasma and stool concentration of bacterial derived metabolites

    The dynamic changes of plasma and stool concentration of bacterial derived metabolites or small molecules (eg: short chain fatty acids (SCFAs) or lipopolysaccharide (LPS) will be reported shortly before, during and shortly after the consumption of probiotic (low or high doses) as compared to the baseline without treatment.

    Measured: within a year of last participant finalising the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521477
Sponsor's protocol ID
2022-01052
Acronym
HISTEPPA
Status last verified
Jan 2025
First submitted
23 Aug 2022
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SLAB51 in people with Alzheimer Disease, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of plasma AD biomarker, Amyloid (time frame: within a year of last participant finalising the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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