MIMIGA Study Title: Modification of Intestinal Microbiome in Patients with Primary IgA Nephropathy (IgAN) Objective: To evaluate whether supplementation with short-chain fatty acids (SCFAs)-specifically sodium butyrate-can reduce proteinuria and slow the progression of chronic kidney disease (CKD) in patients with IgAN by modulating the gut microbiome. Study Design: Type: Randomized, double-blind, placebo-controlled, crossover clinical trial. Participants: Adults with biopsy-proven IgA nephropathy and matched healthy controls. Phases: Treatment Period 1: 12 weeks of SCFA or placebo. Washout Period: 12 weeks. Treatment Period 2: Crossover-those who received SCFA get placebo and vice versa for 24 weeks. Follow-up: 4-8 weeks post-treatment. Primary Endpoint: ≥25% reduction in proteinuria (urinary protein-creatinine ratio) from baseline at week 12 and 24. Secondary and Exploratory Endpoints: Changes in: eGFR (kidney function) Inflammatory cytokines (IL-1, IL-6, IL-10, TNF-α) Gut microbiome composition (via 16S rRNA sequencing) Progression to CKD stage 4 Systolic blood pressure Serum lipids Quality of life (KDQOL-36 questionnaire) Safety Monitoring: Adverse events, especially gastrointestinal issues. Blood and urine biochemistry. Clinical symptoms and patient-reported outcomes. Eligibility Criteria: Inclusion: Adults with IgAN, stable on RAS inhibitors, eGFR ≥ 30 ml/min/1.73 m². Exclusion: Diabetes, other kidney or autoimmune diseases, recent use of immunosuppressants or antibiotics, uncontrolled hypertension, liver disease, pregnancy. Microbiome Analysis: DNA from stool samples analyzed using next-generation sequencing (NGS) targeting the V3-V4 regions of the 16S rRNA gene. Expected Impact: Provide first clinical evidence for SCFA as a safe, cost-effective therapy to slow CKD progression in IgAN. Open new research directions for gut microbiome-targeted treatments in nephrology and other fields (e.g., diabetes, immunology).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Drug: Sodium Butyrate (SCFA) Oral sodium butyrate 400 mg capsule once daily, double-blind; matching appearance to placebo. Sequence A: SCFA for 12 weeks → 12-week washout → placebo for 24 weeks. Drug: Placebo Matching oral capsule once daily, no active SCFA, double-blind. Sequence B: Placebo for 12 weeks → 12-week washout → sodium butyrate 400 mg once daily for 24 weeks.
University Hospital Martin
Martin, Slovakia
Reduction of proteinuria
Reduction of proteinuria by ≥25% from baseline, measured using the spot morning urine protein-creatinine ratio (UPCR)
Time frame: Change from baseline assessed at Week 12 (primary endpoint), with follow-up assessment at Week 24
Change in eGFR
Change in eGFR (CKD-EPI equation) from baseline to week 24
Time frame: Change from baseline assessed at Week 24
Change in cytokine level
Change in cytokine levels: IL-1, IL-6, IL-10, TNF-α
Time frame: Change from baseline assessed at Week 24
Change in gut microbiota composition
Change in gut microbiota composition (diversity indices; phylum/genus level)
Time frame: Change from baseline assessed at Week 24
Change in systolic blood pressure
Change in systolic blood pressure
Time frame: Change from baseline assessed at Week 24
Change in serum lipid profile
Change in serum lipid profile (cholesterol, triglycerides, etc.)
Time frame: Change from baseline assessed at Week 24
Change in quality of life
Change in quality of life using KDQOL™-36 questionnaire
Time frame: Change from baseline assessed at Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.