NCT06767592Completed
A Study of Probiotics in IgA Nephropathy
A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
IgA nephropathy (IgAN) occurs when a specific form of the IgA antibody lodges on the kidneys and causes damage, which may lead to kidney failure. This form of IgA is likely to come from the gut and the upper airways. Recent studies have shown that the bacteria that live in these areas may be different in IgAN. We think that the interaction between these and the immune system triggers production of the IgA that leads to kidney damage. We will examine these bacteria in detail, and test whether a probiotic can alter this favorably, and reduce harmful forms of IgA production in IgAN.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 9 Oct 2023
- Start date
- 13 Oct 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- University of Leicester
- Diseases
- IgA nephropathy
- NCT number
- NCT06767592
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 13 Oct 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
- 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
- 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
Other illness
- Any other condition which in the opinion of the investigator could interfere with the study
- Allergy to any component of BioKult Advanced (including milk or soy allergy)
Lab values
- eGFR \< 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
Age
- Aged \<18 years
Other
- Unable or unwilling to give informed consent
- Predicted to change diet during the study
- Enrolled in a clinical trial of an investigational medicinal product
Who the study is looking for
- Biopsy-proven IgAN
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand the patient information sheet and complete questionnaires
- No change in medications for 6 weeks up to the Baseline visit
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leicester General Hospital, University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.