NCT03228563

Brief Summary

Probiotics could attenuate renal function deterioration in CKD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

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

May 23, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

4.2 years

First QC Date

July 21, 2017

Last Update Submit

July 20, 2022

Conditions

Chronic Kidney DiseaseProbioticsRenal Function

Outcome Measures

Primary Outcomes (1)

  • eGFR decline rate.

    Compare estimated glomerular filtration rate decline rate within baseline, 3, 6, 9 and 12 months after taking probiotics.

    12 months.

Secondary Outcomes (3)

  • Change rate in serum pro-inflammatory cytokines (TNF-α, IL6 and IL18) and endotoxin.

    12 months

  • Average scores of gastrointestinal symptoms by questionnaire.

    12 months.

  • Relative abundance of intestinal microbiota.

    12 months.

Study Arms (2)

Probiotics

EXPERIMENTAL

Taking two capsules of probiotics twice daily for 12 months.

Other: Probioics

Healthy control

NO INTERVENTION

Healthy volunteers were: no hypertension (Blood pressure\<140/90mmHg), no diabetes (Glucose AC 70\~100mg/dl), no hyperlipidemia (Cholesterol Total 130\~200mg/dL、Triglyceride\<150mg/dL), no urinary protein (-) and normal renal function (eGFR\>90), after signing the consent form, the stool samples will be collected.

Interventions

ProbioicsOTHER

CKD Patients were supplemented with two capsules of probiotics containing 2.5\*10\^9 CFU Lactobacillus acidophilus (TYCA06), Bifidobacterium longum (BLI-02) and Bifidobacterium bifidum (VDD088) twice daily for 12 months.

Probiotics

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ‧Stage 3-5 CKD patients, at least 20 years of age and regular follow-up for at least 6 months prior to enrollment.

You may not qualify if:

  • Pregnancy.
  • On immunosuppressive therapy.
  • Active infectious condition.
  • Acute kidney injury.
  • Consuming other forms of probiotics.
  • Taking antibiotics within 30 days prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 413, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • I-kuan Wang

    China Medical University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 25, 2017

Study Start

May 23, 2017

Primary Completion

August 19, 2021

Study Completion

April 30, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

TW(1)