Alternations of Intestinal Microbiota and Health Impact i... | NCT03794401

Studies
Alternations of Intestinal Microbiota and Health Impact in CKD

NCT03794401

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Status

Unknown status

Last Update Posted

Mar 2, 2022Actual

Enrollment

750Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Jan 1, 2019

First Submission Date that Met QC Criteria

Jan 4, 2019

First Posted Date

Jan 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Szu-Chun Hung, Attending physician, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationPrincipal Investigator

Lead Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

750Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
renal outcome	a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation	3-year follow-up
cardiovascular outcome	a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke	3-year follow-up

Secondary Outcomes

Measure	Description	Time Frame
all-cause mortality	CV death or non-CV death	3-year follow-up
neurological outcome	the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years

Other Outcomes

Measure	Description	Time Frame
change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years	the change of lean body mass	2-year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with CKD stage 3-5 defined as eGFR <60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.

Exclusion Criteria:

Patients with active cancer
Patients with liver cirrhosis
Patients have taken antibiotics within three months before screening for inclusion.
Patients with a cardiac pacemaker or metallic implants,
Patients are amputees
Pregnant women
Patients with inherited renal diseases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Regional Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TING-YUN LIN	Contact	+886-2-66289779	2350	water_h2o_6@hotmail.com

Overall Officials

Name	Affiliation	Role
SZU-CHUNG HUNG	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Tzu Chi Hospital	Recruiting	New Taipei City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided