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NCT05521477Completed

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

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

Source: ClinicalTrials.gov · Last updated 23 Jan 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
3 (actual)
First submitted
23 Aug 2022
Start date
1 Sept 2022
Primary completion date
28 Feb 2024
Lead sponsor
University Hospital, Geneva
NCT number
NCT05521477

What you commit to

  • Study type: Interventional
  • Participants enrolled: 3
  • From 1 Sept 2022 to the primary completion date, 28 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Antibiotic consumption 1 month prior the intervention
  • Prebiotic consumption 1 month prior the intervention

Other illness

  • Clinical diagnosis of dementia.
  • 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.

Other

  • Recent change in diet habit (eg: vegetarian, vegan, high protein diet)
  • Current alcohol addiction
  • Current smoking habit
  • Contraindications to probiotic consumption
  • Inability to undergo the procedures of the study, e.g., severe behavioural disturbances.

Who the study is looking for

  • 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

Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Geneva University hospitals - Memory clinic
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.