Celiac DiseaseProCoChoLNCT06178107
Efficacy of Cholesterol-lowering L. Plantarum on Cardiometabolic Health Biomarkers in Coeliac Disease Patients
A study testing LP-LDL Probiotic in people with Celiac Disease, run by University of Roehampton at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- LP-LDL Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Apr 2022to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 65 years, with CD Diagnosis
- Fasting blood glucose level not above 5.6-6.9mmol/L
- High baseline cholesterol (TC> 6mmol / L).
- HbA1c below 5.7%
- With cholesterol
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
Who cannot join
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
- People who are already participating in a weight loss programme
- People receiving drug treatment for lipid metabolisms (e.g., statins
- People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
- All capsules (probiotic and placebo) have the same taste and appearance and have been mixed, encapsulated and packaged to ensure product consistency throughout the study. All capsules will be distributed free of charge to participants in this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Uoc Di Gastroenterologia Aou S. Giovanni Di Dio E Ruggi D'Aragona
Salerno, 84131
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: UOC DI GASTROENTEROLOGIA AOU S.GIOVANNI DI DIO E RUGGI D'ARAGONA (Italy) & University of Roehampton (UK)
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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- LP-LDL Probiotic, Placebo Comparator
- Keywords
- PROBIOTICS, HIGH CHOLESTEROLEMIA
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-LDL ProbioticDietary supplement
Also called Placebo Comparator
LP-LDL a dietary food supplement probiotic
Placebo ComparatorDietary supplement
Placebo comparator Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus plantarum (LPLDL®) equivalent to 4 x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water. Receives: Dietary Supplement: LP-LDL Probiotic |
| placebo | Placebo comparator | Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water. Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood cholesterol levels
To test, in humans, whether LPLDL® intervention lowers total cholesterol compared to the baseline levels
Measured: Change from baseline to 6 and 9 weeks of the intervention
Change in BMI (body mass index) Scores
To test wheter LPLDL® intervention affect body mass indes in kg/m^2
Measured: Change from baseline to 6 and 9 weeks of the intervention
Secondary outcomes (4)
Change in the gut microbiota diversity
To determine the effect of LPLDL® on the faecal microbiota composition and microbial composition express as ratio compared to the baseline levels
Measured: Change from baseline to 6 and 9 weeks of the intervention
Change in dietary habits
To conduct an assessment of dietary intake in the study population using a validated four-day food diary compared to the baseline levels
Measured: Change from baseline to 6 and 9 weeks of the intervention
Change in VitD levels
To determine the effect of LPLDL® in VITD profile express in mmol/L compared to the baseline
Measured: Change from baseline to 6 and 9 weeks of the intervention
Change in ApoB concentration
To determine the effect of LPLDL® in ApoB levels express in mmol/L in comparison to baseline levels
Measured: Change from baseline to 6 and 9 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start12 Apr 2022
- Primary completion30 Jul 2024
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blinded, randomised of parallel design pilot study will include 50 adults aged 18-65 with coeliac disease (CD). After an initial screening, potential subjects will be assessed for inclusion in the run-in trial. Those subjects who meet the inclusion criteria will be then invited to the intervention study for a total duration of 9 weeks, followed by 3 weeks follow up.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Adele Costabile, Prof, Study director, Roehampton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178107
- Sponsor's protocol ID
- LSC 23/ 395
- Acronym
- ProCoChoL
- Status last verified
- May 2026
- First submitted
- 17 Nov 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UOC DI GASTROENTEROLOGIA AOU S.GIOVANNI DI DIO E RUGGI D'ARAGONA (Italy) & University of Roehampton (UK)
- ClinicalTrials.gov ID
- NCT06178107
- Acronym / sponsor ID
- ProCoChoL / LSC 23/ 395
- Conditions
- Celiac Disease
- Keywords
- PROBIOTICS, HIGH CHOLESTEROLEMIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double blinded, randomised of parallel design pilot study will include 50 adults aged 18-65 with coeliac disease (CD). After an initial screening, potential subjects will be assessed for inclusion in the run-in trial. Those subjects who meet the inclusion criteria will be then invited to the intervention study for a total duration of 9 weeks, followed by 3 weeks follow up.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: LP-LDL ProbioticLactobacillus plantarum (LPLDL®) equivalent to 4 x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water. |
| placebo | Placebo comparator | Dietary Supplement: Placebo ComparatorMaltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 65 years, with CD Diagnosis
- Fasting blood glucose level not above 5.6-6.9mmol/L
- High baseline cholesterol (TC> 6mmol / L).
- HbA1c below 5.7%
- With cholesterol
Key exclusion criteria (8 listed)
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
- People who are already participating in a weight loss programme
- People receiving drug treatment for lipid metabolisms (e.g., statins
- People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-LDL ProbioticAlso: Placebo ComparatorLP-LDL a dietary food supplement probiotic | Dietary supplement | Probiotic |
| Placebo ComparatorPlacebo comparator Maltodextrin | Dietary supplement | placebo |
Primary outcome
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
4 secondary outcomes
Change in the gut microbiota diversity
Time frame: Change from baseline to 6 and 9 weeks of the intervention
Change in dietary habits
Time frame: Change from baseline to 6 and 9 weeks of the intervention
Change in VitD levels
Time frame: Change from baseline to 6 and 9 weeks of the intervention
Change in ApoB concentration
Time frame: Change from baseline to 6 and 9 weeks of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Costabile, Prof study director
Roehampton University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LP-LDL Probiotic in people with Celiac Disease, run by University of Roehampton at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood cholesterol levels (time frame: Change from baseline to 6 and 9 weeks of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.