NCT05359094

Brief Summary

This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration 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

First Submitted

Initial submission to the registry

April 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 23, 2024

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

April 27, 2022

Last Update Submit

July 19, 2024

Conditions

Chronic Kidney Disease

Keywords

ProbioticsChronic kidney disease

Outcome Measures

Primary Outcomes (3)

  • Estimated glomerular filtration rate (eGFR) measurement

    The eGFR level is a maker for kidney function

    Baseline to 24 week

  • Blood Urea Nitrogen (BUN) levels

    Blood Urea Nitrogen

    Baseline to 24 week

  • Electrolytes Analysis

    The concentration of electrolytes analysis in the subject's blood samples

    Baseline to 24 week

Secondary Outcomes (12)

  • Uremic toxins assay

    Baseline to 24 week

  • Sugar test

    Baseline to 24 week

  • Nutrition status

    Baseline to 24 week

  • Inflammation makers

    Baseline to 24 week

  • Liver function

    Baseline to 24 week

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Probiotics

ACTIVE COMPARATOR

Probiotics

Dietary Supplement: Probiotics

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo (Microcrystalline α-cellulose) supplement with a Plant-Dominant Low-Protein Diet

Placebo
ProbioticsDIETARY_SUPPLEMENT

Probiotics(Pediococcus acidilactici GKA4) supplement with a Plant-Dominant Low-Protein Diet

Probiotics

Eligibility Criteria

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

You may qualify if:

  • Aged over 20 years old.
  • Patients with 2\~3a stage chronic kidney disease.
  • Those who can cooperate with the research plan for 3 visits and retain samples (blood, urine).

You may not qualify if:

  • Use of other probiotics during the study.
  • Those with active infectious diseases in the past month.
  • Those who have used antibiotics within the past 1 month or during the study.
  • Women who are pregnant or breastfeeding.
  • Obstructive nephropathy within the past month.
  • Polycystic kidney disease (polycystic kidney disease).
  • Acute kidney disease within the past 3 months.
  • Gastrointestinal bleeding within the past 3 months.
  • Malignancy.
  • Severe cardiovascular disease (cardiovascular disease) in the past 3 months, such as coronary artery disease (coronary artery disease), myocardial ischemia (myocardial ischemia), NYHA class IV myocardial failure, cerebrovascular disease, or peripheral artery disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan

Taichung, ROC, 40705, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Cheng-Hsu Chen, MDPHD

    Division of Nephrology in Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 3, 2022

Study Start

June 1, 2022

Primary Completion

August 8, 2023

Study Completion

July 15, 2024

Last Updated

July 23, 2024

Record last verified: 2023-03

Locations

TW(1)