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The Effect of Probiotic Supplementation

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ClinicalTrials.gov Identifier: NCT04390347
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Loughborough University
Yakult Honsha Co., LTD
Chinese University of Hong Kong
Universitaire Ziekenhuizen Leuven
Yakult Honsha European Research Center, ESV
Information provided by (Responsible Party):
University of Leicester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Dietary Supplement: Yakult Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind randomised controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
Experimental: Intervention
The intervention product (Yakult) (supplied as fermented milk) and placebo will be delivered in sealed pots of 65 mL with date stamped expiry. Yakult contains Lactobacillus casei Shirota (a minimum of 6.5 × 109 live cells of Lactobacillus casei Shirota are contained in each pot).
Dietary Supplement: Yakult
A fermented milk product with live microorganisms.

Placebo Comparator: Placebo
The placebo will be indistinguishable (identical in taste and colour but will not contain Lactobacillus casei Shirota) to both participants and trial investigators. It will be stored and provided in exactly the same manner as the intervention product.
Dietary Supplement: Placebo
A milk product with no live microorganisms.




Primary Outcome Measures :
  1. Blood circulating endotoxin concentration [ Time Frame: 6 months ]
    Gut derived toxic particle


Secondary Outcome Measures :
  1. Blood circulating p-cresyl sulphate concentration [ Time Frame: 6 months ]
    Translocated marker of cardiovascular risk

  2. Blood circulating indoxyl sulphate concentration [ Time Frame: 6 months ]
    Translocated marker of cardiovascular risk

  3. Faecal bacterial load [ Time Frame: 6 months ]
    Marker of altered microbiota

  4. Faecal bacterial diversity [ Time Frame: 6 months ]
    Marker of altered microbiota

  5. Faecal ammonia concentration [ Time Frame: 6 months ]
    Marker of altered microbiota

  6. Faecal indole concentration [ Time Frame: 6 months ]
    Marker of altered microbiota

  7. Faecal phenol concentration [ Time Frame: 6 months ]
    Marker of altered microbiota

  8. Faecal p-cresol concentration [ Time Frame: 6 months ]
    Marker of altered microbiota

  9. Faecal calprotectin concentration [ Time Frame: 6 months ]
    Marker of intestinal inflammation

  10. Faecal elastase concentration [ Time Frame: 6 months ]
    Marker of intestinal inflammation

  11. Salivary immunoglobulin A concentration [ Time Frame: 6 months ]
    Marker of mucosal immunity

  12. Salivary lysozyme concentration [ Time Frame: 6 months ]
    Marker of mucosal immunity

  13. Blood circulating interleukin-6 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  14. Blood circulating interleukin-10 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  15. Blood circulating tumour necrosis factor alpha concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  16. Blood circulating high sensitivity c-reactive protein concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  17. Blood circulating interleukin-17 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  18. Blood circulating monocyte chemoattractant protein (MCP)-1 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  19. Blood circulating interleukin-8 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  20. Blood circulating RANTES concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  21. Blood circulating intercellular cell-adhesion molecule 1 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  22. Blood circulating vascular cell adhesion molecule 1 concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  23. Blood circulating E-selectin concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  24. Blood circulating P-selectin concentration [ Time Frame: 6 months ]
    Marker of systemic inflammation

  25. Exhaled Volatile Organic Compounds [ Time Frame: 6 months ]
    Marker of altered microbiota

  26. Kidney disease quality of life instrument (KDQOL) [ Time Frame: 6 months ]
    Quality of life questionnaire

  27. EQ-5D-5L [ Time Frame: 6 months ]
    Quality of life questionnaire

  28. Gastrointestinal Symptom Rating Scale [ Time Frame: 6 months ]
    Measure of gastrointestinal symptoms


Other Outcome Measures:
  1. Number of deaths (all causes) [ Time Frame: 6 months ]
    Mortality

  2. Number of hospital admissions (all causes) [ Time Frame: 6 months ]
  3. Hospital length of stay (days) [ Time Frame: 6 months ]
  4. Number of active infections [ Time Frame: 6 months ]
  5. Supplement compliance as a percentage [ Time Frame: 6 months ]
  6. Food frequency questionnaire [ Time Frame: Change at 6 months compared to baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be a prevalent haemodialysis patient (>3 months)
  2. Age 18 years or older
  3. Able and willing to give informed consent
  4. Sufficient understanding of English to understand the patient information sheet and complete questionnaires

Exclusion Criteria:

  1. Aged <18 years
  2. Unable or unwilling to give informed consent
  3. Unlikely to remain on haemodialysis for the 6-month duration of the trial (e.g. planned transplantation)
  4. Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota
  5. Any of the following conditions:

    1. Documented allergy or intolerance to milk protein (e.g. lactose intolerance, milk/dairy allergy)
    2. Autoimmune disease (e.g. systemic lupus erythematosus)
    3. Inflammatory bowel disease (e.g. Crohn's colitis)
    4. Diagnosed infectious illness within the previous 30-days
  6. Prescribed any of the following medication:

    1. Antibiotics or anti-viral medications within the previous 30-days
    2. Steroids or other immunosuppressive agents -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390347


Contacts
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Contact: Daniel S March, PhD 01162231498 dsm12@le.ac.uk
Contact: James O Burton, MD jb343@le.ac.uk

Locations
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United Kingdom
University Hospitals of Leicester Recruiting
Leicester, Leicestershire, United Kingdom
Contact: Daniel March, PhD         
Sponsors and Collaborators
University of Leicester
Loughborough University
Yakult Honsha Co., LTD
Chinese University of Hong Kong
Universitaire Ziekenhuizen Leuven
Yakult Honsha European Research Center, ESV
Publications:
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04390347    
Other Study ID Numbers: 0760
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data collected for the study, and a data dictionary defining each field in the set, will be made available to others on specific to request to the Chief Investigator and corresponding authors provided all regulatory and data sharing approvals are obtained after. These data will be available after publication of study findings.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The study protocol, the statistical analysis plan, and the informed consent form are available throughout the duration of the trial. Requests should be made to the study contact or Chief Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Leicester:
dialysis
probiotic
randomised
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency