Combined Probiotic Lactiplantibacillus plantarum ECGC 13110402 and Plant Sterol Supplement May Improve Lipids and Gut Microbiota in Coeliac Adults: A Randomised, Placebo-Controlled Pilot Human Intervention Study.

Adele Costabile, Lorretta Olu Fagbemi, Carlo Soldaini, Monica Siniscalchi, Monica Ruotolo, Monica Barone, Marco Fabbrini, Patrizia Brigidi, Silvia Turroni, Sofia Kolida, Yvonne Jeanes, Carolina Ciacci

Journal: Molecules (Basel, Switzerland) 2026;31(10):

PMID: 42197276

Abstract

Evidence suggests that a gluten-free diet may increase the risk of metabolic abnormalities associated with cardiovascular disease in adults with Coeliac Disease (CeD). This 9-week, double-blind, placebo-controlled, randomised pilot study investigated the effects of a combined supplement containing probiotic Lactiplantibacillus plantarum ECGC 13110402 and plant sterols and stanols, on cardiometabolic biomarkers and gut microbiota diversity and composition in adults with CeD and hypercholesterolaemia. Blood lipid profiles and vitamin D concentrations were analysed, and gut microbiota was profiled via 16S rRNA amplicon sequencing. In the active group, significant reductions in total cholesterol, LDL-cholesterol, non-HDL cholesterol, and apolipoprotein B were observed at multiple time points during the treatment phase, with changes generally greater in magnitude compared with the placebo group. Vitamin D levels also increased in the active group during supplementation. Microbiota analysis revealed potentially beneficial changes in participants receiving the active formulation, including higher alpha diversity and higher proportions of Bifidobacterium spp., Christensenellaceae R-7 group, and Lachnospiraceae ND3007 group. Overall, this feasibility study provides exploratory findings that a combined Lactiplantibacillus plantarum ECGC 13110402-phytosterol formulation may support lipid management and beneficially modulate gut microbiota in adults with CeD, particularly for those seeking non-pharmacological approaches to improving cardiometabolic health biomarkers.

Address: School of Life and Health Sciences, University of Roehampton, London SW15 5PU, UK.; Department of Medicine, Surgery and Dentistry Scuola Medica Salernitana, University of Salerno, 84081 Fisciano, Italy.; UOC GSSS/PL Servizio di Dietetica e Nutrizione Clinica, Via Antonio Cardarelli, 80131 Napoli, Italy.; Human Microbiomics Unit, Department of Medical and Surgical Sciences, University of Bologna, 40126 Bologna, Italy.; Human Microbiomics Unit, Department of Medical and Surgical Sciences, University of Bologna, 40126 Bologna, Italy.; IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.; IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.; Unit of Microbiome Science and Biotechnology, Department of Pharmacy and Biotechnology, University of Bologna, 40138 Bologna, Italy.; OptiBiotix Health PLC, York YO10 5DG, UK.; Education, Research & Professional Practice Team-British Dietetic Association, Birmingham B3 2TA, UK.
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