A Study of Probiotics in IgA Nephropathy

Launched by UNIVERSITY OF LEICESTER · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of probiotics on patients with IgA nephropathy (IgAN), a kidney condition that can lead to kidney damage and possibly failure. Researchers believe that certain bacteria in the gut and upper airways may play a role in causing the harmful IgA antibodies that damage the kidneys. By studying these bacteria and testing a probiotic (a type of good bacteria that can help your gut health), the trial aims to see if it can help reduce harmful IgA production and improve kidney health.

To participate in this study, you need to be 18 years or older and have been diagnosed with IgAN through a kidney biopsy. It’s important that you haven’t changed your diet or medications in the weeks leading up to the study. Participants can expect to provide informed consent, complete questionnaires, and undergo tests to monitor their kidney health during the trial. If you have certain medical conditions or have recently taken specific medications, you may not be eligible to join. This study is currently recruiting participants, and all genders are welcome to apply.

Gender

ALL

Eligibility 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)