Sponsor study identifier
interventional
80
1 country
1
Study Start
December 16, 2019
Actual (reported)Primary Completion
February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patients with chronic kidney disease (CKD) display a substantial increase in cardiovascular disease (CVD). Moreover, the prognosis of CVD in CKD is extremely poor. Understanding the pathophysiology of CVD in CKD might help to develop treatment strategies to reduce its morbidity and mortality. Compelling evidence suggests that the uremic milieu itself plays a critical role in the development and progression of CVD in CKD. The gut microbiota is markedly altered in CKD. Fermentation of protein and amino acids by certain gut microbiota results in the generation of different uremic toxins. p-cresyl sulfate (PCS) is among the most representative gut-derived uremic toxins implicated in the pathogenesis of CVD in CKD. However, there remained no clear cut-off value of fasting plasma PCS for unfavorable clinical outcomes. Thus, we plan to establish an oral tyrosine challenge test (OTCT) integrated with dietary patterns, gut microbiome, and serum biochemistry to assess PCS synthesis capacity from host-diet-microbiota interactions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2019
Actual (reported)December 16, 2019
Actual (reported)December 18, 2019
Actual (reported)February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
level of serum p-cresyl sulfate
serum p-cresyl sulfate level after oral tyrosine loading up to 48 hours
the area under curve of serum p-cresyl sulfate
level of serum phenyl sulfate
the area under curve of serum phenyl sulfate
tyrosine at a dose of 100 mg/kg is then administered orally to the participants once
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Taipei Tzu Chi Hospital
New Taipei City, 231, Taiwan
Lin TY, Hung SC, Abe T. An oral tyrosine challenge test for functional phenotyping of microbiota-derived phenyl sulfate production. NPJ Metab Health Dis. 2026 Jun 2;4(1):20. doi: 10.1038/s44324-026-00114-4.
Ting-Yun Lin, MD.
Taichung Tzu Chi Hospital
First Submitted
December 8, 2019
First Posted
December 18, 2019
Study Start
December 16, 2019
Actual (reported)Primary Completion
February 28, 2020
Estimated (date passed)Low Protein Diet, Gut Microbiome and Chronic Kidney Disease
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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