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Effects of probiotics on chronic kidney disease: a randomized cross-over controlled trial

Effects of probiotics on chronic kidney disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039722
Enrollment
Unknown
Registered
2020-11-06
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic renal disease

Interventions

Group 1a~1c:Probiotic
Group 1d:Placebo
Group 2a~2c:Probiotic
Group 2d:Placebo
Group 3a~3c:Probiotic
Group 3d:Placebo
Group 4a~4c:Probiotic
Group 4d:Placebo
Group 5a~5c:Probiotic
Group 5d:Placebo

Sponsors

Wuxi Second Hospital Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Non dialysis diabetic nephropathy group (1) Patients with diabetic nephropathy were diagnosed; (2) Patients with EGFR = 90ml / min / 1.73m2.

Exclusion criteria

Exclusion criteria: 1. Non dialysis diabetic nephropathy group (1) Patients with the following diseases or discomfort: malignant tumor, HIV, urinary system disease or malformation (except kidney disease), liver disease affecting albumin level, acute severe infection, severe malnutrition, autoimmune disease, congestive heart failure (stage III / IV), acute and chronic enteritis, primary kidney disease, acute renal failure, urinary incontinence, onset in the last month They have had urinary tract infection, gastric bleeding, gastrointestinal surgery, and abnormal secretion or pruritus of external genitalia; (2) Patients with the following treatment history: dialysis in the past 1 month, use of phosphorus bond, cathartic, iron, antibiotics, probiotics or synbiotics, perineal lotion, antioxidant or anti-inflammatory drugs (Vit E, Vit C, omega-3), immunosuppressant in the past 3 months, and indwelling catheterization or enema in 2 weeks; (3) Patients during menstruation or pregnancy; (4) Patients who are unable to communicate with each other or are unconscious. 2. Non diabetic nephropathy and non dialysis group (1) Patients with the following diseases or discomfort: malignant tumor, HIV, urinary system disease or malformation (except kidney disease), liver disease affecting albumin level, acute severe infection, severe malnutrition, autoimmune disease, congestive heart failure (stage III / IV), acute and chronic enteritis, acute renal failure, urinary incontinence, urinary tract infection in recent 1 month Gastric bleeding, gastrointestinal surgery, abnormal secretion or pruritus of external genitalia; (2) Patients with the following treatment history: dialysis in the past 1 month, use of phosphorus bond, cathartic, iron, antibiotics, probiotics or synbiotics, perineal lotion, antioxidant or anti-inflammatory drugs (Vit E, Vit C, omega-3), immunosuppressant in the past 3 months, and indwelling catheterization or enema in 2 weeks; (3) Patients during menstruation or pregnancy; (4) Patients who are unable to communicate with each other or are unconscious. 3. Diabetic nephropathy hemodialysis group (1) Patients with the following diseases or discomfort: malignant tumor, HIV, urinary system disease or malformation (except kidney disease), liver disease affecting albumin level, acute severe infection, severe malnutrition, autoimmune disease, congestive heart failure (stage III / IV), acute and chronic enteritis, acute renal failure, urinary incontinence, urinary tract infection in recent 1 month Gastric bleeding, gastrointestinal surgery, abnormal secretion or pruritus of external genitalia; (2) Patients with the following treatment history: they have used phosphate bond, cathartic, iron, antibiotics, probiotics or synbiotics, perineal lotion, antioxidants or anti-inflammatory drugs (Vit E, Vit C, omega-3) and immunosuppressants in recent 3 months, and received indwelling catheterization or enema within 2 weeks; (3) Patients during menstruation or pregnancy; (4) Patients who are unable to communicate with each other or are unconscious. 4. Diabetic nephropathy peritoneal dialysis group (1) Patients with the following diseases or discomfort: malignant tumor, HIV, urinary system disease or malformation (except kidney disease), liver disease affecting albumin level, acute severe infection, severe malnutrition, autoimmune disease, congestive heart failure (stage III / IV), acute and chronic enteritis, acute renal failure, urinary incontinence, urinary tra

Design outcomes

Primary

MeasureTime frame
Hepatorenal function;Endotoxin;C-reactive protein;Immunity index;Glycosylated hemoglobin;Blood insulin;Vital signs;24-hour urine output;Life quality score;Patient subjective overall nutritional status assessment;Depression Self-rating scale;Morisky medication compliance questionnaire;

Countries

China

Contacts

Public ContactNinghan Feng

Wuxi Second Hospital Affiliated to Nanjing Medical University

fnh888@njmu.edu.cn+86 13813952696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026