Probiotics in IgA Nephropathy

January 29, 2013 updated by: Hilde Kloster Smerud, Uppsala University Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Linköping, Sweden
        • Linkoping University Hospital
        • Contact:
          • Anders Fernström, MD PhD
        • Principal Investigator:
          • Anders Fernström, MD PhD
      • Stockholm, Sweden
        • Karolinska University Hospital
        • Contact:
          • Sigrid Lundberg, MD PhD
        • Principal Investigator:
          • Sigrid Lundberg, MD PhD
      • Uppsala, Sweden
        • Uppsala University Hosptial
        • Contact:
          • Bengt Fellström, MD PhD
        • Principal Investigator:
          • Bengt Fellström, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProTectis
Dietary supplement: ProTectis
Experimental: Gastrus
Dietary supplement: Gastrus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in albuminuria
Time Frame: Baseline and 3 months
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in renal function
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in IgA/IgG immune complexes
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in hematuria
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in immunological markers in blood
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in IBS (irritable bowel syndrome) symptoms
Time Frame: Baseline and 3 months
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 3 months and 5 months
3 months and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Karolinska Institutet
University Hospital, Linkoeping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMR-2712 (Other Identifier: Protocol writer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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