SYMBIOTiC Study – SYMptom, microBIOme and dieT in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Symptom burden; Uraemic syndrome; Quality of life; Renal and Urogenital - Kidney disease; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12619000442101
• Lead Sponsor: niversity of Wollongong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2021-09-03
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Participants diagnosed with stage 3-4 CKD non-dialysing/ pre-dialysis (eGFR 15-59mL/min per 1.73m2) or individuals deemed suitable by the medical team (Nephrologist).
- Adults (aged 18 years old or more)
- Participants must be able to give informed consent; i.e. have no major cognitive or sensory impairment

Exclusion Criteria

•Individuals who are less than 18 years of age
•Individuals with intellectual or mental impairment as well as those with a hearing impairment will only be excluded if they cannot follow safety simple instructions due to concerns relevant to the safety of the patient.
•Individuals receiving dialysis
•Individuals diagnosed with dysphagia and/or require texture modified diet
•Any women who are found to be pregnant during the trial would need to be immediately excluded due to the increased medical demands of a pregnancy in kidney disease.
•Individuals with past or present radiation to the bowel or large bowel resection
•Individuals with advanced colorectal cancer
•Individuals who consumed antibiotic therapy within 1 months of study commencement
•Individuals with medically diagnosed irritable bowel syndrome, crohn’s disease or ulcerative colitis;
•Individuals who have had a clinically significant change to their immunosuppressant dose within the last 6 months (determined by the medical team) of study commencement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in urine concentrations of at least 1 of 2 uraemic toxins (Indoxyl Sulfate and p-Cresyl Sulfate)[Assessed baseline (week 1), end of first arm (week 6), end of washout/ second baseline (week 10) and end of second arm (week 16).];Change in plasma concentrations of at least 1 of 2 uraemic toxins (Indoxyl Sulfate and p-Cresyl Sulfate)<br><br>[Assessed baseline (week 1), end of first arm (week 6), end of washout/ second baseline (week 10) and end of second arm (week 16).]