Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06767592

A Study of Probiotics in IgA Nephropathy

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) 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.

CONDITIONS

Official Title

A Study of Probiotics in IgA Nephropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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