Clinical Trial Details

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

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Trial Information

Broad Health Condition Renal and Urogenital
Diet and Nutrition

Specific Health ConditionKidney disease
Other diet and nutrition disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Wollongong Hospital - Wollongong
St George Hospital - Kogarah


Postcode
2500 - Wollongong
2217 - Kogarah

Anticipated date of first participant enrolment6/05/2019

Anticipated date of last participant enrolment6/05/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This trial aims to investigate the effects of a novel renal dietary intervention (rich in plant foods, utilising a whole food dietary approach) designed to improve diet quality, symptom burden, the gastrointestinal microbiome as well as other health outcomes in adults with moderate-severe, pre-dialysis chronic kidney disease. It is anticipated that this trial will improve overall diet quality by increasing the volume and variety of plant foods, improve quality of life and symptoms such as constipation, result in changes to the microbial community present in the gastrointestinal tract of participants and hence, observe a reduced production of gut microbiome derived metabolites/toxins which may include indoxyl sulfate and p-Cresyl sulfate
Eligibility

Key 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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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 pre- or probiotics or 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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Wollongong
Primary Sponsor Address: University of Wollongong Northfields Avenue Wollongong, NSW, 2522
Primary Sponsor Country: Australia

Trial IDACTRN12619000442101

UTNU1111-1227-1769

Contact person for information and recruitmentMs
Jordan Stanford
Building 41 University of Wollongong Northfields Avenue Wollongong NSW, 2522
+61 2 4221 4600

Further information iconjs096@uowmail.edu.au
Australia