The objective of the study is to see whether oral administration of probiotics can modulate certain immunological markers which are associated with accelarated atherosclerosis in patients with ANCA associated vasculitis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- phenotype of the CD4+/CD28- T-cells
- measurement of other lymphocyte subsets (NK cells en regulatory T-cells)
these cells will be tested on specificity for HSP-60 antigen
- quantitive measurement of circulating HSP-60 en HSP-60 antibodies
- quantitive measurement of circulating interleuking 10
- selected CD4+/CD28- T-cells stimulation tests with measurement of IL-10
production and intracellular cytokins
Secondary outcome
not applicable
Background summary
Cerebrovascular accidents en myocardial infarction are complications of
atherosclerosis. Atherosclerosis is a chronic vascular disease in which
inflammation is an important factor. The etiology of this inflammation is not
yet illucidated. Research however showed that humoral immunlogical mechanisms
may play a pivotal role. Antibodies against oxidated LDL and heat shock protein
60 (HSP-60) seem to be the most relevant. Also antigen specific T-cells have
been isolated from athersclerotic plaques. Anti neutrophil cytoplasmatic
antibodies (ANCA) associated vasculitis is a chronic inflammatory vessel
disease. Patients with ANCA asssociated vasculitis seem to have an increased
risk for cardiovascular complications. HSP-60 antibodies and a increase in CD
4+ / CD28- T-cell counts are associated with this increase in risk. Research
demonstrated that these T-cells are antigen specific to HSP-60. Certain
probiotic are able to decrease interferon gamma (atherogenic) levels in plasma
and to increase interleukin 10 ( anti atherogenic). Furthermore probiotics
which produce HSP-60 may induce tolerance for HSP-60.
Study objective
The objective of the study is to see whether oral administration of probiotics
can modulate certain immunological markers which are associated with
accelarated atherosclerosis in patients with ANCA associated vasculitis.
Study design
In this pilot study ten patients will be selected with a proven ANCA associated
vasculitis and increased CD4+/CD28- T-cell count. There will be a period of 16
weeks follow up. The first four weeks patients will be administered either a
placebo or pro-biotics, hereafter there will be a four week lasting period of
wash-out. The last four weeks patients will crossover to probiotics or placebo.
At week 0, 4 , 8, 12 and 16 blood will be drawn for immunological essays (see
below). Patients will be asked to fill out a questionaire te evaluate the
compliance.
Intervention
The intervention will be administration of probiotics. Imunnological parameters
before and after administration will be compared.
Study burden and risks
Extent of burden:
- 5 times visit to outpatient clinic
- 5 times a blood test
- to fill out a questionaire
- to bring the used sachets to the outpatient clinic
P Debijelaan 25
6202 AZ Maastricht
Nederland
P Debijelaan 25
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
patients with ANCA associated vasculits
increased CD4+/CD28- T-cell counts
Exclusion criteria
No significant immunosupressive therapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12434.068.06 |