Microbiome and Dementia
The Gut-Brain Axis in Dementia: Biomarker and Novel Intervention Strategies
1 other identifier
observational
43
1 country
1
Brief Summary
From this study, it is hoped to learn if and how the gut microbiome composition, gut permeability and inflammation in patients with dementia are associated with each other. Dysbiosis may lead to an increased gut permeability, bacterial translocation and inflammation which may influence pathogenesis and progression of dementia. The novel aspect of the study will be to understand the association between gut microbiome composition, gut permeability and the presence of dementia. This will help to better understand the pathogenesis of dementia and lead to the development of novel therapeutic strategies. If this hypothesis holds true, the study will be the basis to develop new treatment options for dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
July 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2020
CompletedOctober 9, 2024
October 1, 2024
12 months
May 15, 2017
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Alpha diversity
Chao1 index
single measurement at baseline
Secondary Outcomes (3)
gut permeability
single measurement at baseline
bacterial translocation
single measurement at baseline
inflammation
single measurement at baseline
Study Arms (2)
dementia
patients with dementia
control
healthy control
Eligibility Criteria
Patients with dementia and age matched healthy controls
You may qualify if:
- Age \>18y
- Dementia (Alzheimer type and mixed type)
- Informed consent signed by the patient or his legal representative
- Mini Mental State Examination ≤ 26
You may not qualify if:
- Other forms of dementia
- Inflammatory bowel diseases
- Liver cirrhosis
- Antibiotic treatment within the last 14 days
- Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
- Healthy controls
- Age \>18y
- Informed consent
- No known acute or chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, 8010, Austria
Related Publications (1)
Stadlbauer V, Engertsberger L, Komarova I, Feldbacher N, Leber B, Pichler G, Fink N, Scarpatetti M, Schippinger W, Schmidt R, Horvath A. Dysbiosis, gut barrier dysfunction and inflammation in dementia: a pilot study. BMC Geriatr. 2020 Jul 20;20(1):248. doi: 10.1186/s12877-020-01644-2.
PMID: 32690030DERIVED
Biospecimen
Stool, serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2017
First Posted
May 30, 2017
Study Start
July 7, 2017
Primary Completion
July 2, 2018
Study Completion
July 16, 2020
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share