IgA Nephropathy
Conditions
Brief summary
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.
Interventions
DIETARY_SUPPLEMENTProTectis
DIETARY_SUPPLEMENTGastrus
Sponsors
University Hospital, Linkoeping
Karolinska Institutet
Uppsala University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Above 18 years * Primary IgAN, verified by biopsy * Albuminuria \> 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion) * Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion) * Having signed informed consent form
Exclusion criteria
* Participation in another clinical intervention trial * Patients with celiac disease * Patients with secondary IgAN * Creatinine clearance below 30 ml/min (mean of 3 measurements) * Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion * Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months * Patients using probiotic products within the last three months (includes probiotic milk products) * Known allergy or intolerance to any of the ingredients in the probiotic product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in albuminuria | Baseline and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in renal function | Baseline and 3 months |
| Change in IgA/IgG immune complexes | Baseline and 3 months |
| Change in immunological markers in blood | Baseline and 3 months |
| Change in IBS (irritable bowel syndrome) symptoms | Baseline and 3 months |
| Change in hematuria | Baseline and 3 months |
Other
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 months and 5 months |
Countries
Sweden
Contacts
Primary ContactBengt Fellström, MD PhD
Backup ContactHilde K Smerud, PhD
Outcome results
None listed