Probiotics in IgA Nephropathy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Uppsala University Hospital
Sponsor:
Collaborators:
University Hospital, Linkoeping
Karolinska Institutet
Information provided by (Responsible Party):
Hilde Kloster Smerud, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01781312
First received: January 16, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
IgA Nephropathy
Dietary Supplement: ProTectis
Dietary Supplement: Gastrus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Change in albuminuria [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in renal function [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in IgA/IgG immune complexes [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in hematuria [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in immunological markers in blood [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in IBS (irritable bowel syndrome) symptoms [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months and 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProTectis Dietary Supplement: ProTectis
Experimental: Gastrus Dietary Supplement: Gastrus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781312

Contacts
Contact: Bengt Fellström, MD PhD bengt.fellstrom@medsci.uu.se
Contact: Hilde K Smerud, PhD hilde.smerud@medsci.uu.se

Locations
Sweden
Linköping University Hospital Not yet recruiting
Linköping, Sweden
Contact: Anders Fernström, MD PhD         
Principal Investigator: Anders Fernström, MD PhD         
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Sigrid Lundberg, MD PhD         
Principal Investigator: Sigrid Lundberg, MD PhD         
Uppsala University Hosptial Not yet recruiting
Uppsala, Sweden
Contact: Bengt Fellström, MD PhD         
Principal Investigator: Bengt Fellström, MD PhD         
Sponsors and Collaborators
Uppsala University Hospital
University Hospital, Linkoeping
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Hilde Kloster Smerud, Clinical Research Scientist, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01781312     History of Changes
Other Study ID Numbers: SMR-2712, SMR-2712
Study First Received: January 16, 2013
Last Updated: January 29, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014