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Clinical Trials/NCT01781312
NCT01781312UnknownNot Applicable

Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients

Uppsala University Hospital3 sites in 1 country20 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
3
Primary Endpoint
Change in albuminuria
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in albuminuria

Time Frame: Baseline and 3 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hilde Kloster Smerud

Clinical Research Scientist

Uppsala University Hospital

Study Sites (3)

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