ProBiotix Health, a life sciences company developing pioneering probiotic solutions for cardiometabolic health, has announced the publication of a new pilot human intervention study demonstrating the efficacy of its patented probiotic strain Lactobacillus plantarum ECGC 13110402, LPLDL®, in adults with coeliac disease (CeD) and hypercholesterolaemia. It is the first published clinical investigation evaluating LPLDL® in this patient population.
The randomised, placebo-controlled pilot human intervention study was conducted over 9 weeks followed by a three-week washout period at UOC of Gastroenterology of the AOU Ruggi d’Aragona of Salerno in Italy. It found that adults with CeD and hypercholesterolaemia, taking one bilayer tablet containing 25mg of LPLDL® and 400mg of PSS (Plant Sterols and Stanols) twice daily, showed consistent improvements in atherogenic lipid markers, including LDL-cholesterol, total cholesterol, non-HDL-cholesterol and apolipoprotein B, compared to the placebo-matched participants. The active group also demonstrated positive changes in gut microbiota composition, including increased microbial diversity and higher levels of beneficial bacterial groups.
These findings also contribute to the growing body of evidence found in previous studies carried out by ProBiotix Health, further demonstrating that the inclusion of LPLDL® within multi-ingredient formulations has a positive impact on key cardiometabolic health biomarkers.
Dr. Adele Costabile, Professor in Clinical Nutrition and the Microbiome at the University of Roehampton, who led the investigation, commented: “These key findings continue to show that LPLDL®, combined with PSS, can support lipid management and beneficially modulate gut microbiota in adults with CeD. Although untreated CeD is often associated with low cholesterol due to impaired nutrient absorption, cholesterol levels frequently increase to normal levels following adoption of a gluten-free diet, leaving many patients with the same cardiometabolic challenges as the wider population. This study represents the first clinical investigation of LPLDL® in adults with coeliac disease and marks an important first step in addressing an unmet need to support cardiometabolic and intestinal health in adults with CeD beyond dietary management alone.”
Participants were instructed to maintain their usual dietary intake and physical activity levels, while avoiding other probiotic products that could influence gastrointestinal motility or lipid metabolism. Key findings after the 9-week treatment phase and three-week washout period highlighted:
Statistically significant reduction in total cholesterol levels, with reductions of 12.3% at week 5, 16% at week 9, and 13.4% after washout.
Significant reduction in LDL cholesterol by 11% (whereby previous studies suggested a decrease between 5-12% with consumption of higher PSS doses).
A significant decrease in non-HDL cholesterol by 19%, compared to an 11% reduction for the placebo group.
A significant decrease in apolipoprotein B concentrations by 19% for the active group only, an important biomarker of cardiovascular risk.
Higher alpha diversity, a hallmark of intestinal and systemic health, and increased proportions of Bifidobacterium, Christensenellaceae R-7, and Lachnospiraceae ND3007, in the active group only.
Observed a significant increase in vitamin D levels of those in the active group. This finding warrants further investigation to support future formulaic opportunities combining LPLDL® and vitamin D.
Steen Andersen, CEO at ProBiotix Health, added: “Every new clinical study strengthens the evidence base behind LPLDL® and gives our partners greater confidence when selecting a clinically validated ingredient for differentiated cardiometabolic products. This latest study is particularly exciting since it demonstrates positive outcomes in a new patient population, while highlighting our continued commitment to scientific excellence and a compelling commercial proposition for the value of LPLDL® in combination with complementary cardiometabolic ingredients”.
As a patented probiotic strain designed to support cardiometabolic health, LPLDL® was initially selected from a collection of over 4,000 microbial candidates for its superior bile salt hydrolase activity and cholesterol reduction activity, in combination with its ability to survive in high concentrations of bile salts.
Previous independent human intervention studies have shown that daily intake of LPLDL® has a positive impact on multiple cardiometabolic health biomarkers, including total, LDL and HDL cholesterol, apolipoprotein B, triglycerides and blood pressure.
To discover more about LPLDL® and its demonstrated efficacy for cardiometabolic health, visit probiotixhealth.com or visit our team at CPHI Milan on 6 – 8 October 2026 at stand 16C80, Hall 16.
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