NCT04307121

Brief Summary

Growing evidences showed that patients with chronic constipation accompanied with intestinal dysbiosis. Gut dysbiosis is a harbinger of chronic inflammation, yet the underlying basis is unclear. Plasma level of microbial translocation is a marker of mucosal permeability. Increased mucosal permeability ignites elevated microbial translocation and is a source of systemic immune activation in CKD patients. The passage of microbial components from the gastrointestinal tract into the systemic circulation may be an important contributor to the chronic inflammatory process and subsequent atherosclerosis development. We plan to determine the association constipation with biomarkers of inflammation such monocyte activation and associated cytokines as well as markers of microbial translocation including endotoxin and its antibodies, intestinal barrier proteins of 200 hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 11, 2020

Last Update Submit

January 29, 2021

Conditions

ConstipationInflammation

Keywords

constipationmicrobial translocationinflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Microbial Translocation Markers

    Plasma level of microbial translocation is a marker of mucosal permeability. Increased mucosal permeability ignites elevated microbial translocation and is a source of systemic immune activation in CKD patients. microbial translocation including endotoxin and its antibodies, intestinal barrier proteins

    1 years

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hemodialysis (HD) patients

You may qualify if:

  • Hemodialysis for more than 3 months and Age older than 20 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

ConstipationInflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic 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 13, 2020

Study Start

March 10, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

TW(1)