UOC DI GASTROENTEROLOGIA AOU S.GIOVANNI DI DIO E RUGGI D'ARAGONA (Italy) & University of Roehampton (UK)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Celiac Disease
- Sponsor
- University of Roehampton
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in blood cholesterol levels
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies suggest the existence of other factors capable of contributing to the onset of the disease, such as intestinal dysbiosis. We have also seen how each of us has a specific microbiota, defined as an individual human enterotype, which depends on our background and can be modified by the diet. Recently, much interest has been directed to a strain of lactobacilli, called Lactobacillus plantarum (LP-LDL®) capable of reducing cholesterol and preventing the reabsorption of bile salts in the liver. The efficacy of this bacterial strain has been confirmed in 3 different human studies demonstrating the efficacy of LP-LDL® in patients with high baseline cholesterol (TC> 6mmol / L). This is a food supplement that has been commercially available in multiple formulations in Europe for over 3 years. LP-LDP is a probiotic strain, safe to use, selected for its high bile salt hydrolase in vitro, and in vivo cholesterol reduction activity. The intake of 2 Å~ 109 CFU encapsulated LP-LDL twice daily, significantly reduced LDL-C (13.9%), total cholesterol (TC) (37.6%), TG (53.9%), and significantly increased HDL-C (14.7%; in subjects >60 years of age; 6-12 weeks) in normal to mildly hypercholesterolaemic subjects. In a recent double-blind placebo-controlled human study published by the Journal of Functional Foods (2022) and carried out by the University of Roehampton (UK), LPLDL showcased statistically significant reductions in multiple cardiovascular risk biomarkers, including total cholesterol, LDL cholesterol, non-HDL cholesterol and apoB. No adverse effects were noted throughout the study.
We are here proposing a pilot human intervention study to evaluate the effectiveness of the LP-LDL® probiotic in reducing cardiovascular risk factors inclusive of cholesterol in the blood in people with coeliac disease.
Detailed Description
A total of 50 coeliac subjects (+/- 6 additional volunteers) will be recruited to achieve statistical significance with changes on a logarithmic scale of 1.2 for cholesterol based on other interventional studies using focused probiotics on the reduction of the lipid picture. Based on these calculations, 10 coeliac subjects are required for each study group. The Mann-Whitney U test will be used to compare variables that are not normally distributed. GraphPad Prism Version 9.0 (GraphPad Software, Inc., San Diego, CA, USA) will be used for statistical analysis. All patients with coeliac disease will be recruited at Roehampton until the set target by the Protocol (at least 25 patients will be enrolled). This is to ensure we have an acceptable number of patients that can be monitored, net of subjects lost to follow up (drop-out). A random generator (GraphPad QuickCalcs, San Diego, CA, USA) will be used in order to assign a specific number to each patient and ensure double-blind randomization of the 50 patients in two study groups. Patients will be stratified by gender and randomly assigned to one of the two treatment groups using a 2: 1 ratio due to the higher prevalence of female sex in coeliac patients.
Investigators
DR ADELE COSTABILE
Study PI
University of Roehampton
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in blood cholesterol levels
Time Frame: Change from baseline to 6 and 9 weeks of the intervention
To test, in humans, whether LPLDL® intervention lowers total cholesterol compared to the baseline levels
Change in BMI (body mass index) Scores
Time Frame: Change from baseline to 6 and 9 weeks of the intervention
To test wheter LPLDL® intervention affect body mass indes in kg/m\^2
Secondary Outcomes
- Change in VitD levels(Change from baseline to 6 and 9 weeks of the intervention)
- Change in the gut microbiota diversity(Change from baseline to 6 and 9 weeks of the intervention)
- Change in ApoB concentration(Change from baseline to 6 and 9 weeks of the intervention)
- Change in dietary habits(Change from baseline to 6 and 9 weeks of the intervention)