We want to map the entire bacterial ecosystem in the gastrointestinal tract of patients with IgA nephropathy, in order to gain insight into the processes that may play a role in the development of the disease. This can then lay the foundation for…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does the gastro-intestinal bacterial ecosystem between patients with IgA
nephropathy differ from control renal patients and healthy controls? If so, in
what way?
Secondary outcome
1. Can disruption of the gastrointestinal bacterial ecosystem be linked to
disease severity?
2. Are there associations between health traits/dietary habits and the
gastrointestinal bacterial ecosystem?
Background summary
IgA nephropathy is a slowly progressing disease that causes kidney damage and
leads to kidney failure in about 25-50% of cases. For them, dialysis or renal
transplantion is the only solution. The reason why IgA nephropathy develops in
some people is unclear and there is no effective treatment yet. The disease is
characterized by the precipitation of IgA in the kidneys. IgA is made by immune
cells and helps to protect us against infection. The IgA in the blood is
normally strongly bound to sugar molecules. In IgA nephropathy patients,
something appears to go wrong with the saccharification of the IgA in the
blood, causing it to precipitate in the kidneys and eventually leading to
kidney damage. An important role in the development of IgA nephropathy appears
to be played by immune cells that make IgA in our gastrointestinal mucosa. The
IgA they secrete is naturally low in sugars and binds bacteria in the
gastrointestinal tract and has a substantial influence on the composition of
the bacterial ecosystem in the gastrointestinal tract. An interesting
observation in this regard is that the bacterial ecosystem in the saliva and
stool of IgA nephropathy patients is different from that of healthy people.
This could indicate a disturbance of the immune system in the gastrointestinal
tract of IgA nephropathy patients. Little is known about this at the moment.
Study objective
We want to map the entire bacterial ecosystem in the gastrointestinal tract of
patients with IgA nephropathy, in order to gain insight into the processes that
may play a role in the development of the disease. This can then lay the
foundation for new forms of treatment.
Study design
This is a clinical observational study.
Study burden and risks
This is an observational study in which participants complete a questionnaire,
have their blood pressure measured and donate body fluids (urine, sputum,
faeces and blood). In our view, there are no risks associated with this. The
burden for participation in this study is minimal and consists of a 1-hour
visit to our outpatient clinic.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Biopsy-proven
eGFR 15 - 90 ml/min/1.73m2
Age 18 - 70 years
Exclusion criteria
No informed consent
Secondary causes of glomerular IgA depositions:
- Liver disease; cirrhosis, hepatitis B
- Gastro-intestinal disease; inflammatory bowel disease (IBD), celiac disease,
major gastro-intestinal surgery
- Skin disease; dermatitis herpetiformis, psoriasis
- Pulmonary disease
- Malignant disease
- Current infection
- IgA monoclonal gammopathy
- The use of immunosuppressive drugs
- Antibiotic treatment < 3 months
- CKD stage 5 / dialysis
- Pregnancy
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 | NL78440.091.21 |