A Study of Probiotics in IgA Nephropathy

NCT06767592 | Recruiting

• 1 other identifier: 0718
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline.

  The primary outcome, change in circulating IgA O-glycans levels between baseline and 3-months, will be analysed.

  3 months

Secondary Outcomes (2)

• Urine protein/creatinine ratio (UP/C) over a 6-month period

  Up to Month 6

• eGFR over a 6 month period

  Up to Month 6

Study Arms (1)

Probiotic

EXPERIMENTAL

Participants will receive the multi-strain probiotic, Bio-Kult Advanced, 2 capsules twice daily between baseline and month 3 visits.

Dietary Supplement: Bio-Kult Advanced

Interventions

Bio-Kult Advanced DIETARY_SUPPLEMENT

Bio-Kult Advanced will be provided as capsules and can be stored at room temperature. Participants will be instructed to swallow two capsules in the morning and two capsules in the evening, with food.

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Aged \<18 years
• Unable or unwilling to give informed consent
• eGFR \< 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
• Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
• Predicted to change diet during the study
• Any of the following conditions:
• 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
• Any other condition which in the opinion of the investigator could interfere with the study
• Enrolled in a clinical trial of an investigational medicinal product
• Allergy to any component of BioKult Advanced (including milk or soy allergy)

Sponsors & Collaborators

• University of Leicester: lead
• Kidney Cancer UK: collaborator

Study Sites (1)

Leicester General Hospital, University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: January 10, 2025
• Study Start: October 13, 2023
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)