Verifying the validity of urinary kryptopyrrole (UKP) testing in an adult population: Protocol for a multi-stage research project

Abstract

IntroductionUrinary kryptopyrroles (UKP) are described as pyrrole compounds excreted in urine and have been associated with a broad range of signs and symptoms. However, causality between elevated UKP and the described symptoms of pyrrole disorder have not been established. A four stage project has been developed to verify the validity of a urinary kryptopyrroles test and attempt to establish a reference range for a healthy population. MethodsStage one will consist of a survey to clinicians who are currently using UKP testing in their practice to understand their perceptions of the clinical value and applicability of the test in addition to identifying the condition for stage three. Stage two consists of a clinical trial to establish a normal reference range for UKP in a healthy population. Stage three is a clinical trial exploring the correlation, if any, between UKP in a diagnosed health condition to the healthy population group. Stage four is a pragmatic trial assessing UKP levels in patients as used by clinicians as part of routine clinical practice. RecruitmentRecruitment for stage one will be via email invitation to SAFE Analytical laboratories Pty Ltd customer database. Stage two and three will be targeting the wider community in the greater Brisbane area in Queensland and aims to recruit 120 participants per stage. Recruitment for stage four will be conducted through community based clinical practices. ConclusionAt the conclusion of all stage, the validation of the UKP test from SAFE Analytical laboratories will be analysed. Formulation of a reference range for a healthy population range will be explored and compared to a diagnosed condition and other conditions as tested by clinicians in practice.