Effects of probiotics and fibers on markers of nephropathy, inflammation, intestinal barrier dysfunction and endothelial dysfunction in individuals with type 1 diabetes and albuminuria. The ProFOS Study

J Diabetes Complications. 2024 Dec;38(12):108892. doi: 10.1016/j.jdiacomp.2024.108892. Epub 2024 Oct 24.

Abstract

Aims: To estimate whether a mix of pre- and probiotics would strengthen the gut barrier and protect the kidneys in individuals with type 1 diabetes and albuminuria.

Methods: Randomized, placebo-controlled, crossover study. Forty-one participants received synbiotic (pre- and probiotics) mix or placebo for 12 weeks with 6 weeks washout. Primary endpoint was change from baseline to end-of-period in UACR. Secondary endpoints were changes in endothelial glycocalyx thickness, inflammatory and intestinal barrier dysfunction markers, glomerular filtration rate (GFR) and ambulatory systolic blood pressure.

Results: Thirty-five participants completed the study. Mean age was 58 (SD 10) years, 73 % (n = 30) were male, median UACR was 134 (IQR 63-293) mg/g, estimated GFR was 75 (30) ml/min/1.73m2. There was no significant difference in UACR with a mean relative change (CI 95 %) from baseline to end-of-treatment of -3.0 (-18.4; 15.5) % in the synbiotic group and -12.0 (-29.6; 9.6) % in the placebo group with no significant difference between treatment periods (9.37 (-25.2; 44.0) percentage points; p = 0.60). No significant beneficial difference in the secondary end points was demonstrated.

Conclusion: Twelve weeks treatment with synbiotic mix had no effect on UACR or on any of the secondary endpoints in subjects with type 1 diabetes and albuminuria.

Keywords: Gut microbiota; Kidney disease; Type 1 diabetes.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Albuminuria*
  • Biomarkers* / analysis
  • Cross-Over Studies*
  • Diabetes Mellitus, Type 1* / complications
  • Diabetic Nephropathies* / diagnosis
  • Diabetic Nephropathies* / physiopathology
  • Diabetic Nephropathies* / therapy
  • Dietary Fiber / administration & dosage
  • Endothelium, Vascular / drug effects
  • Endothelium, Vascular / physiopathology
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Inflammation
  • Intestinal Mucosa / drug effects
  • Intestinal Mucosa / metabolism
  • Intestinal Mucosa / pathology
  • Male
  • Middle Aged
  • Probiotics* / administration & dosage
  • Probiotics* / therapeutic use
  • Synbiotics / administration & dosage

Substances

  • Biomarkers
  • Dietary Fiber