A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Leicester General Hospital, University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 25
Treatments
Experimental: Probiotic
Participants will receive the multi-strain probiotic, Bio-Kult Advanced, 2 capsules twice daily between baseline and month 3 visits.
Related Therapeutic Areas
Sponsors
Collaborators: Kidney Cancer UK
Leads: University of Leicester

This content was sourced from clinicaltrials.gov