Pro-IgAN

• Research type

  Research Study

• Full title

  A single-arm open-label exploratory study of Probiotics for the modulation of the gut microbiome in IgA Nephropathy (Pro-IgAN)

• IRAS ID

  293225

• Contact name

  Chee Kay Cheung

• Contact email

  ckc15@le.ac.uk

• Sponsor organisation

  University of Leicester

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Recent studies have demonstrated a link between impaired gastrointestinal barrier integrity, increased gastrointestinal permeability and reactivity, and IgA nephropathy (IgAN). Alterations to the gut microbiome (dysbiosis) may influence mucosal IgA production deleteriously in IgAN. Probiotic supplementation may have beneficial effects on these processes. In this study, we will study the efficacy and safety of a multi-strain probiotic in patients with IgAN.

  The study will be an open-label cross-over trial of 25 adult patients with IgAN. Participants will undergo baseline characterisation, spend Months 0-3 on the probiotic and Months 3-6 off the probiotic, to investigate the effect of probiotic ingestion on biomarkers of mucosal immunity, the gut microbiome, and the faecal, plasma and urine metabolome, in IgAN.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  21/WM/0075

• Date of REC Opinion

  22 Apr 2021

• REC opinion

  Further Information Favourable Opinion