Probiotic Supplements in Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-07-15

Brief Summary

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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.

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Detailed Description

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Chronic kidney disease (CKD) with gut microbiota was different from a normal person. Some gut microbiota produces short-chain fatty acids or induces functional enzymes beneficial to patients. On the other hand, some gut microbiota may also metabolize amino acids into p-cresol and indole which were leading to the accumulation of urinary toxins and damage to the kidney. This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins, inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with CKD.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Probiotics

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Probiotics

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Use of other probiotics during the study.
2. Those with active infectious diseases in the past month.
3. Those who have used antibiotics within the past 1 month or during the study.
4. Women who are pregnant or breastfeeding.
5. Obstructive nephropathy within the past month.
6. Polycystic kidney disease (polycystic kidney disease).
7. Acute kidney disease within the past 3 months.
8. Gastrointestinal bleeding within the past 3 months.
9. Malignancy.
10. 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No