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.
- 2026-05-19
- Molecules (Basel, Switzerland) 31(10)
- 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
- PubMed: 42197276
- DOI: 10.3390/molecules31101722
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- adults with Coeliac Disease (CeD) and hypercholesterolaemia
- Methods
- 9-week, double-blind, placebo-controlled, randomised pilot study; combined supplement containing probiotic Lactiplantibacillus plantarum ECGC 13110402 and plant sterols and stanols
- Blinding
- Double-blind
- Duration
- 9 weeks
- Funding
- Unclear
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.