Probiotics in IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01781312
• Other study ID #: SMR-2712
• Secondary ID: SMR-2712
• Status: Not yet recruiting
• Phase: N/A
• First received: January 16, 2013
• Last updated: January 29, 2013
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2013
• Source: Uppsala University Hospital
• Contact: Bengt Fellström, MD PhD
• Email: bengt.fellstrom[@]medsci.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Dietary Supplement:
• ProTectis

• Gastrus

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hosptial	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	Karolinska Institutet, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months and 5 months	Yes
Primary	Change in albuminuria		Baseline and 3 months	No
Secondary	Change in renal function		Baseline and 3 months	No
Secondary	Change in IgA/IgG immune complexes		Baseline and 3 months	No
Secondary	Change in hematuria		Baseline and 3 months	No
Secondary	Change in immunological markers in blood		Baseline and 3 months	No
Secondary	Change in IBS (irritable bowel syndrome) symptoms		Baseline and 3 months	No