Probiotics in IgA Nephropathy

Not Applicable

• Conditions: IgA Nephropathy
• Interventions: Dietary Supplement: ProTectis; Dietary Supplement: Gastrus

• Registration Number: NCT01781312
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-29
• Last Update Submitted: 2013-01-29
• Study First Posted: 2013-01-31
• Last Update Posted: 2013-01-31
• Primary Completion: 2014-07
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProTectis	ProTectis	-
Gastrus	Gastrus	-

Primary Outcome Measures

Name	Time	Method
Change in albuminuria	Baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
Change in renal function	Baseline and 3 months
Change in IgA/IgG immune complexes	Baseline and 3 months
Change in hematuria	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

Trial Locations

Locations (3)

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hosptial; 🇸🇪 Uppsala, Sweden