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Randomized Controlled Trial
. 2024 Dec;38(12):108892.
doi: 10.1016/j.jdiacomp.2024.108892. Epub 2024 Oct 24.

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

Elisabeth B Stougaard  1 , Ninna Hahn Tougaard  2 , Suvanjaa Sivalingam  2 , Christian Stevns Hansen  2 , Joachim Størling  3 , Tine Willum Hansen  2 , Marie Frimodt-Møller  2 , Robert E Steinert  4 , Soheil Varasteh  5 , Per-Henrik Groop  6 , Hanne Salmenkari  7 , Markku J Lehto  6 , Frederik Persson  2 , Peter Rossing  8
Affiliations
Randomized Controlled Trial

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

Elisabeth B Stougaard et al. J Diabetes Complications. 2024 Dec.

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.

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Conflict of interest statement

Declaration of competing interest EBS, NHT, SS, HS and ML have no conflicts of interest. RES and SV are employees of dsm-firmenich, Kaiseraugst, Switzerland. PHG has received lecture fees from Astellas, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Elo Water, Genzyme, Medscape, MSD, Mundipharma, Novartis, Novo Nordisk, PeerVoice, Sanofi, and Sciarc. He is an advisory board member for AbbVie, Astellas, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Medscape, MSD, Mundipharma, Novartis, Novo Nordisk, and Sanofi. None of these entities participated in the design or interpretation of the study. FP has served as a consultant, on advisory boards or as educator for AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Sanofi, Mundipharma, MSD, Novartis, Amgen and has received research grants to institution from Novo Nordisk, Boehringer Ingelheim, Amgen and AstraZeneca. PR has received consultancy and/or speaking fees (to SDCC) from AbbVie, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Eli Lilly, MSD, Novo Nordisk and Sanofi Aventis, and research grants from Novo Nordisk Bayer and AstraZeneca. JS and TWH have shares in Novo Nordisk A/S.

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