Probiotics in IgA Nephropathy
Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
1 other identifier
interventional
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJanuary 31, 2013
January 1, 2013
1.5 years
January 16, 2013
January 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in albuminuria
Baseline and 3 months
Secondary Outcomes (5)
Change in renal function
Baseline and 3 months
Change in IgA/IgG immune complexes
Baseline and 3 months
Change in hematuria
Baseline and 3 months
Change in immunological markers in blood
Baseline and 3 months
Change in IBS (irritable bowel syndrome) symptoms
Baseline and 3 months
Other Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
3 months and 5 months
Study Arms (2)
ProTectis
EXPERIMENTALGastrus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Above 18 years
- Primary IgAN, verified by biopsy
- Having signed informed consent form
You may not qualify if:
- Participation in another clinical intervention trial
- Patients with celiac disease
- Patients with secondary IgAN
- Creatinine clearance below 30 ml/min (mean of 3 measurements)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala University Hospitallead
- University Hospital, Linkoepingcollaborator
- Karolinska Institutetcollaborator
Study Sites (3)
Linköping University Hospital
Linköping, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hosptial
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Scientist
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 31, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
January 31, 2013
Record last verified: 2013-01