Probiotic Supplements in Chronic Kidney Disease

Taichung Veterans General Hospital

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05359094

SF22054A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

Probiotics

Active Comparator group

Description:

Probiotics

Treatment:

Dietary Supplement: Probiotics