Actively Recruiting
A Study of Probiotics to Alter Gut Microbiome in IgA Nephropathy A Single-Arm Open-Label Feasibility Trial of Bio-Kult Advanced
Led by University of Leicester · Updated on 2025-01-10
25
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
K
Kidney Cancer UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
IgA nephropathy (IgAN) is a condition where a certain form of the IgA antibody builds up in the kidneys, causing damage that can lead to kidney failure. This form of IgA likely originates from the gut and upper airways. Researchers are studying the gut bacteria in people with IgAN, as differences in these bacteria may trigger the immune system to produce harmful IgA. This study aims to better understand this connection and test whether probiotics can influence these bacteria and reduce harmful IgA production. The study will provide participants with a multi-strain probiotic called Bio-Kult Advanced, given as capsules to be taken twice daily with food. This probiotic was chosen because previous research showed reduced gut microbial diversity in patients with progressive IgAN. The study will characterize the gut microbiome and related metabolic markers, then assess any changes after probiotic use. Participants will undergo assessments of their gut bacteria, as well as measurements from fecal, plasma, and urine samples related to immunity and kidney disease. The main outcome is the change in IgA1 antibody glycosylation levels after three months compared to the start. The study collects important data to guide future longer-term trials and to identify markers for disease progression and response to gut-targeted treatments.
CONDITIONS
Official Title
A Study of Probiotics in IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven IgA nephropathy
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand patient information and complete questionnaires
- No medication changes for 6 weeks before baseline visit
- Stable diet for 30 days before baseline visit and during the study (no elimination, reduction, vegan, or vegetarian diet changes)
You will not qualify if you...
- Under 18 years of age
- Unable or unwilling to give informed consent
- Estimated glomerular filtration rate (eGFR) below 45 ml/min/1.73 m2
- Regular use of prebiotic, probiotic, or other gut-modulating dietary supplements in the last 60 days
- Expected diet changes during the study
- Autoimmune diseases such as systemic lupus erythematosus
- Serious gastrointestinal illnesses including Crohn's disease, ulcerative colitis, chronic liver disease, significant gastrointestinal surgery or cancer, pancreatitis, or motility disorders
- Infectious illness diagnosed within the past 30 days
- Use of antibiotics, antiviral, steroids, or immunosuppressive medications in the past 60 days
- Any condition that may interfere with the study in the investigator's opinion
- Participation in another clinical trial involving investigational medicinal products
- Allergy to any component of Bio-Kult Advanced, including milk or soy allergy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE5 4PW
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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