Constipation, Gut Microbiome, and Microbial-derived Uremic Toxins From the Gut Microbiota in HD Patients

NCT04309019 | Completed DMC

• 1 other identifier: 108080
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation; Inflammation

Keywords

constipation, , ,; gut microbiome; uremic toxins; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Stool DNA Isolation and 16S rDNA Gene Amplicon Sequencing

  1 years

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and and undergoing hemodialysis (HD) for at least 6 months.

You may qualify if:

• Patients over age 20 years old
• Undergoing hemodialysis (HD) for at least 6 months

You may not qualify if:

• Inflammatory diseases
• Cancer
• AIDS
• Autoimmune disease
• Use of a central catheter for hemodialysis access
• Amputated limbs
• Pregnancy
• Using catabolic drugs
• Using antioxidant vitamin supplements
• Using symbiotic and antibiotics

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Constipation; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: March 10, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

TW (1)