Testing probiotics for kidney health in IgA nephropathy
A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)
This study is testing if a special mix of probiotics can improve kidney health in people with IgA nephropathy by looking at how gut bacteria affect the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06767592 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of gut bacteria in IgA nephropathy (IgAN), a kidney condition caused by the accumulation of a specific IgA antibody. Researchers will analyze the gut microbiome and related metabolites in patients with IgAN and assess whether a multi-strain probiotic, Bio-Kult Advanced, can positively influence these factors. The study seeks to generate pilot data that could inform future larger trials and identify biomarkers for disease progression and treatment response. By understanding the gut's impact on kidney health, the study hopes to uncover new therapeutic avenues for IgAN.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven IgA nephropathy.
Not a fit: Patients under 18, those with severe kidney impairment, or individuals with certain gastrointestinal or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new probiotic treatments that improve kidney function and slow disease progression in patients with IgAN.
How similar studies have performed: While the approach of using probiotics in kidney disease is emerging, this specific study is novel and aims to provide foundational data for future research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy-proven IgAN 2. Age 18 years or older 3. Able and willing to give informed consent 4. Sufficient understanding of English to understand the patient information sheet and complete questionnaires 5. No change in medications for 6 weeks up to the Baseline visit 6. Stable diet (e.g. not a change to elimination, reduction, vegan or vegetarian diet) for 30-days prior to the baseline visit and during the study Exclusion Criteria: 1. Aged \<18 years 2. Unable or unwilling to give informed consent 3. eGFR \< 45 ml/min/1.73 m2 (measured by CKD-EPI formula) 4. Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days 5. Predicted to change diet during the study 6. Any of the following conditions: 6.1. Autoimmune disease (e.g. systemic lupus erythematosus) 6.2. Serious gastro-intestinal illness (including Crohn's disease, ulcerative colitis, chronic liver disease, significant gastrointestinal surgery or cancer, pancreatitis, motility disorder) 6.3. Diagnosed infectious illness within the previous 30-days 7. Prescribed any of the following medication within the previous 60-days 7.1. Antibiotics or anti-viral medications 7.2. Steroids or other immunosuppressive agents 8. Any other condition which in the opinion of the investigator could interfere with the study 9. Enrolled in a clinical trial of an investigational medicinal product 10. Allergy to any component of BioKult Advanced (including milk or soy allergy)
Where this trial is running
Leicester, Leicestershire
- Leicester General Hospital, University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.