Chronic Kidney Disease Clinical Trial
Official title:
The Effect of Probiotics on Chronic Kidney Disease
Verified date | July 2022 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Probiotics could attenuate renal function deterioration in CKD patients.
Status | Completed |
Enrollment | 148 |
Est. completion date | April 30, 2022 |
Est. primary completion date | August 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Healthy volunteers: The criteria for 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. CKD patients: Inclusion Criteria: ?Stage 3-5 CKD patients, at least 20 years of age and regular follow-up for at least 6 months prior to enrollment. Exclusion Criteria: - Pregnancy. - On immunosuppressive therapy. - Active infectious condition. - Acute kidney injury. - Consuming other forms of probiotics. - Taking antibiotics within 30 days prior to enrollment. |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | eGFR decline rate. | Compare estimated glomerular filtration rate decline rate within baseline, 3, 6, 9 and 12 months after taking probiotics. | 12 months. | |
Secondary | Change rate in serum pro-inflammatory cytokines (TNF-a, IL6 and IL18) and endotoxin. | Compare TNF-a, IL6, IL18 and endotoxin concentration within baseline, 3, 6, 9 and 12 months after taking probiotics. | 12 months | |
Secondary | Average scores of gastrointestinal symptoms by questionnaire. | Gastrointestinal symptoms are evaluated by a study nurse using questionnaire at baseline, 3, 6, 9 and 12 months after intervention. The questionnaire included the stool form [1 = very hard (small hard lumps), 2 = hard stool (hard sausage shape), 3 = normal stool (sausage to banana shape), 4 = soft stool, 5 = muddy stool, 6 = watery stool], ease of defecation (1 = difficult, 2 = easy, 3 = very easy) and abdominal symptoms [frequency of upper abdominal pain, lower abdominal pain, borborygmus, and flatulence (1 = frequent, 2 = occasional, 3 = almost never)]. The average scores before and after the intervention were analyzed. | 12 months. | |
Secondary | Relative abundance of intestinal microbiota. | Stools from the participants were collected before and after 3, 6, 9 and 12-month probiotics treatments for NGS assay. The abundance of Bifidobacterium and Lactobacillus in stool microbiotia will be assessed. | 12 months. |
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