Probiotic L. plantarum ECGC 13110402 combined with plant sterols in hypercholesterolaemic coeliac adults: a randomised controlled pilot trial
Combined supplementation with L. plantarum ECGC 13110402 and plant sterols favoured LDL-cholesterol reduction and gut microbiota changes in hypercholesterolaemic coeliac adults versus placebo, but the small sample size precludes definitive conclusions.
Context
Coeliac adults on a gluten-free diet face elevated cardiometabolic risk, including dyslipidaemia, with no prior evidence base for probiotic-based cholesterol-lowering strategies in this population. The combination of a bile salt hydrolase-active probiotic and intestinal cholesterol-absorption-blocking plant sterols targets two distinct mechanistic pathways. This pilot addresses a recognised evidence gap.
What the study showed
The active group showed a favourable direction of change in LDL-cholesterol at week 9 compared to placebo, alongside gut microbiota compositional shifts. Absolute numbers, relative changes, and 95% confidence intervals are not fully reported in the available text excerpt, preventing precise quantification. No serious adverse events were recorded. The 3-week washout did not allow assessment of effect persistence.
How it was done
Single-centre, randomised, double-blind, placebo-controlled pilot trial conducted at AOU Ruggi d'Aragona, Salerno, Italy. Participants stratified by sex and allocated 1:1 using an independent random number generator. Total duration 12 weeks (9-week intervention + 3-week washout). Assessments at baseline, week 5, week 9, and week 12.
Effect magnitude
Specific effect sizes (RR, OR, MD, or SMD with 95% CI) are not reported in the available text; the pilot design was not powered for definitive efficacy endpoints, rendering clinical magnitude uncertain.
Limitations
Very small sample size (pilot) precludes population-level inference; absence of full 95% CI and effect-size data undermines GRADE evaluation. Single-centre design (Salerno, Italy) limits generalisability. RoB 2 risk-of-bias assessment was not formally applied by authors. Absence of strict dietary control may introduce confounding. The 3-week washout period is insufficient to evaluate durability of lipid and microbiota effects.
In clinical practice
Insufficient evidence exists to recommend this combination as a standard strategy for coeliac adults with dyslipidaemia. Clinicians may regard this as a preliminary safety and tolerability signal, pending adequately powered trials. Standalone plant sterols (1.5–3 g/day reducing LDL by 7–12%) retain established non-pharmacological support and can be considered within current lipid management frameworks.
What is still missing
An adequately powered, multicentre RCT with validated cardiovascular endpoints in coeliac adults is required to confirm the efficacy and long-term safety of this combination.