Probiotics in IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01781312
• Date of registration: 16/01/2013
• Prospective Registration: No
• Primary sponsor: Uppsala University Hospital
• Public title: Probiotics in IgA Nephropathy
• Scientific title: Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
• Date of first enrolment: January 2013
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01781312
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Bengt Fellström, MD PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Dietary Supplement: Gastrus

Dietary Supplement: ProTectis

Primary Outcome(s)

Change in albuminuria [Time Frame: Baseline and 3 months]

Secondary Outcome(s)

Change in renal function [Time Frame: Baseline and 3 months]

Change in IgA/IgG immune complexes [Time Frame: Baseline and 3 months]

Change in hematuria [Time Frame: Baseline and 3 months]

Change in IBS (irritable bowel syndrome) symptoms [Time Frame: Baseline and 3 months]

Change in immunological markers in blood [Time Frame: Baseline and 3 months]

Secondary ID(s)

SMR-2712

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Linkoeping

Karolinska Institutet