NCT04390347Completed
The Effect of Probiotic Supplementation
Daily Intake of Lactobacillus Casei Shirota (LcS) Modulates Intestinal Permeability and Decreases Circulating Levels of Endotoxin That Associate With Both Cardiovascular and All-cause Mortality in Haemodialysis Patients
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
This is a double-blind randomised controlled trial where participants will be randomised to either twice daily 65ml of Lactobacillus casei Shirota for six months or a matched placebo.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 5 May 2020
- Start date
- 21 Sept 2020
- Primary completion date
- 24 Aug 2022
- Lead sponsor
- University of Leicester
- Diseases
- Chronic kidney disease
- NCT number
- NCT04390347
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 21 Sept 2020 to the primary completion date, 24 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unlikely to remain on haemodialysis for the 6-month duration of the trial (e.g. planned transplantation)
- Any of the following conditions:
- Documented allergy or intolerance to milk protein (e.g. lactose intolerance, milk/dairy allergy)
- Autoimmune disease (e.g. systemic lupus erythematosus)
- Inflammatory bowel disease (e.g. Crohn's colitis)
- Diagnosed infectious illness within the previous 30-days
- Prescribed any of the following medication:
- Antibiotics or anti-viral medications within the previous 30-days
- Steroids or other immunosuppressive agents -
Age
- Aged \<18 years
Other
- Unable or unwilling to give informed consent
- Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota
Who the study is looking for
- Be a prevalent haemodialysis patient (\>3 months)
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand the patient information sheet and complete questionnaires
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.