Prospective randomised evaluation of prebiotics in organ transplantation to prevent infectious complications - feasibility study

Not Applicable

Recruiting

• Conditions: Kidney transplant; Kidney disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12618001057279
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-25
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Received an acute kidney transplant at the Princess Alexandra Hospital
Aged equal to or greater than 18 years
Able to provide informed consent

Exclusion Criteria

Have received radiation to the bowel or large bowel resection
Unable to comply with follow-up
Medically diagnosed and active inflammatory bowel disease
Unwilling or unable to meet the requirements of the protocol
Other medical or social reasons for exclusion at the discretion of the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is not the primary outcome<br>The primary outcome for this study is feasibility <br>a) ability to successfully recruit 60 patients within six months<br>b) proportion of eligible patients who agree to take part in the study<br><br>This will be assessed at the end of the clinical trial[Adherence to the Green Banana Resistant Starch will be assessed at the end of the study. The adherence parameter will be measured at the end of the study, i.e. at the eight week mark after kidney transplantation<br>This will be a secondary outcome now<br>Adherence to prebiotic supplementation will be defined as <br>a) proportion of participants adherent to prescribed study therapy (intervention or placebo) over the period of the study]