Probiotics in IgA Nephropathy

• Sponsor: Uppsala University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01781312
• Collaborator: University Hospital, Linkoeping (Other), Karolinska Institutet (Other)
• Enrollment: 20
• Locations: 3
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Dietary Supplement: ProTectis; Dietary Supplement: Gastrus	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2014
• Anticipated Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ProTectis	Dietary Supplement: ProTectis
Experimental: Gastrus	Dietary Supplement: Gastrus

Outcome Measures

Primary Outcome Measures

1. Change in albuminuria [Baseline and 3 months]

Secondary Outcome Measures

1. Change in renal function [Baseline and 3 months]

2. Change in IgA/IgG immune complexes [Baseline and 3 months]

3. Change in hematuria [Baseline and 3 months]

4. Change in immunological markers in blood [Baseline and 3 months]

5. Change in IBS (irritable bowel syndrome) symptoms [Baseline and 3 months]

Other Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [3 months and 5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linköping University Hospital	Linköping		Sweden
2	Karolinska University Hospital	Stockholm		Sweden
3	Uppsala University Hosptial	Uppsala		Sweden

Sponsors and Collaborators

• Uppsala University Hospital
• University Hospital, Linkoeping
• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hilde Kloster Smerud, Clinical Research Scientist, Uppsala University Hospital
• ClinicalTrials.gov Identifier: NCT01781312
• Other Study ID Numbers: SMR-2712; SMR-2712
• First Posted: Jan 31, 2013
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Kidney Diseases; Glomerulonephritis, IGA

Study Results

No Results Posted as of Jan 31, 2013