Sponsor study identifier
observational
61
1 country
1
Study Start
March 10, 2020
Actual (reported)Primary Completion
December 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Chronic constipation is a prevalent, multifactorial gastrointestinal disorder, and its etiology and pathophysiology remain poorly understood. Recently studies using 16S rDNA-based microbiota profiling have demonstrated dysbiosis of gut microbiota in chronic constipation. In addition, alterations of fecal flora of the a group of severely constipated patients had been reported. Constipation, an indicator of gut dysbiosis in dialysis patients, may also pose a greater burden in dialysis patients. Some recent findings highlight the plausible link between the gut and the kidneys and provide additional insights into the pathogenesis of kidney disease progression and development of cardiovascular disease. Yet, the constipation in dialysis patients is usually ignored and not even draw the attention of dialysis physician as an ominous risk factor of constipated dialysis patients. In view of multiple factors link the gut and cardiorenal pathophysiology, and the scarcity of literature on this issue, the aim of this study is want to know if constipation can result in any changes to the intestinal microbiota and is it associated with inflammation, atherogenic profile and levels of microbial derived uremic toxins. Here, the investigators use both self-reported Bristol stool form scale (BSFS) scores and Roman IV criteria to diagnose constipation and 16S rDNA Illumina amplicon profiles of faecal samples of 90 dialysis patients to assess potential associations between microbiota composition and constipation. The relationship between uremic toxins and inflammation will also be explored in the dialysis suffering from constipation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2020
Actual (reported)March 11, 2020
Actual (reported)March 16, 2020
Actual (reported)December 31, 2020
Actual (reported)December 31, 2020
Actual (reported)Serum uremic toxins such as indoxyl sulfate, p-cresol and IAA analysis
gut microbiota composition have been associated with increased production of indoxyl sulfate and p-cresyl sulfate, which is directly associated with endothelial dysfunction, inflammation and oxidative stress, and increases in the incidence of CVD and mortality.
1 years
Stool DNA Isolation and 16S rDNA Gene Amplicon Sequencing
1 years
patients have to be at least 20-years-old and and undergoing hemodialysis (HD) for at least 6 months.
Tungs' Taichung MetroHarbour Hospital
Taichung, Taiwan
Paik Seong Lim, PhD
Tungs' Taichung Metroharbour Hospital
61 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2020
First Posted
March 16, 2020
Study Start
March 10, 2020
Actual (reported)A Caregiver-mediated Health Educational Intervention to Improve Constipation Status of Primary School Children
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
April 29, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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