A Study of Probiotics in IgA Nephropathy

Last updated: January 3, 2025
Sponsor: University of Leicester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Glomerulonephritis

Nephritis

Treatment

Bio-Kult Advanced

Clinical Study ID

NCT06767592
0718
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andcomplete 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

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 supplementaimed 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. Seriousgastro-intestinal illness (including Crohn's disease, ulcerative colitis, chronicliver disease, significant gastrointestinal surgery or cancer, pancreatitis,motility disorder) 6.3. Diagnosed infectious illness within the previous 30-days

  1. Prescribed any of the following medication within the previous 60-days 7.1.Antibiotics or anti-viral medications 7.2. Steroids or other immunosuppressiveagents

  2. Any other condition which in the opinion of the investigator could interfere withthe study

  3. Enrolled in a clinical trial of an investigational medicinal product

  4. Allergy to any component of BioKult Advanced (including milk or soy allergy)

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Bio-Kult Advanced
Phase:
Study Start date:
October 13, 2023
Estimated Completion Date:
May 31, 2026

Study Description

The purpose of this proposal is to conduct a proof of concept study, to test the hypothesis that dysbiosis of the gut microbiota plays a critical role in the development of IgAN.

Objectives are firstly, to characterise the gut microbiome, and faecal, plasma and urine metabolome, in relation to biomarkers of mucosal immunity and glomerular disease in patients with IgAN. Secondly, Investigators will test whether a multi-strain probiotic (Bio-Kult Advanced) produces a modulatory effect on these indices. The probiotic has been selected with our industry collaborator Protexin, based on previous studies demonstrating reduced faecal microbial diversity in patients with progressive IgAN, compared to those with non-progressive IgAN and healthy subjects.

This study will further our understanding of the interplay between the gut microbiome, metabolome, and mucosal immune system in IgAN. Investigators will generate important pilot data, to inform the design of a longer-term randomised clinical trial of probiotics in IgAN, and to identify potential plasma biomarkers to highlight those at risk of progressive disease, and those who may respond to treatments targeted to the gut.

Connect with a study center

  • Leicester General Hospital, University Hospitals of Leicester NHS Trust

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Active - Recruiting

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