Probiotics in IgA Nephropathy
This study is not yet open for participant recruitment.
Verified January 2013 by Uppsala University Hospital
Sponsor:
Uppsala University Hospital
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
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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 |
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
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:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis |
Urologic Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013