The Effect of Probiotic Supplementation

NCT04390347 | Completed DMC

• 1 other identifier: 0760
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

dialysis; probiotic; randomised

Outcome Measures

Primary Outcomes (1)

• Blood circulating endotoxin concentration

  Gut derived toxic particle

  6 months

Secondary Outcomes (31)

• Blood circulating p-cresyl sulphate concentration

  6 months

• Blood circulating indoxyl sulphate concentration

  6 months

• Faecal bacterial load

  6 months

• Faecal bacterial diversity

  6 months

• Faecal ammonia concentration

  6 months

Other Outcomes (6)

• Number of deaths (all causes)

  6 months

• Number of hospital admissions (all causes)

  6 months

• Hospital length of stay (days)

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Yakult DIETARY_SUPPLEMENT

A fermented milk product with live microorganisms.

Intervention

Placebo DIETARY_SUPPLEMENT

A milk product with no live microorganisms.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leicester: lead
• Loughborough University: collaborator
• Yakult Honsha Co., LTD: collaborator
• Chinese University of Hong Kong: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Yakult Honsha European Research Center, ESV: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicestershire, United Kingdom

Location

Related Publications (1)

• Wang IK, Wu YY, Yang YF, Ting IW, Lin CC, Yen TH, Chen JH, Wang CH, Huang CC, Lin HC. The effect of probiotics on serum levels of cytokine and endotoxin in peritoneal dialysis patients: a randomised, double-blind, placebo-controlled trial. Benef Microbes. 2015;6(4):423-30. doi: 10.3920/BM2014.0088. Epub 2015 Feb 12.

  PMID: 25609654 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomised controlled trial

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 15, 2020
• Study Start: September 21, 2020
• Primary Completion: August 24, 2022
• Study Completion: December 31, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

GB (1)