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Study on intestinal flora characteristics and its correlation with clinical features in patients with polycystic kidney disease

Study on intestinal flora characteristics and its correlation with clinical features in patients with polycystic kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088270
Enrollment
Unknown
Registered
2024-08-14
Start date
2023-10-08
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Polycystic kidney disease

Interventions

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of PKD patient group (1) Age 18-80 years old, male and female. (2) All cases followed the unified criteria of the 2020 Clinical Practice Guidelines for Polycystic Kidney Disease (Chinese Medical Association Medical Genetics Branch) and met the diagnostic criteria for polycystic kidney disease (3) No history of antibiotics or probiotics in the past 1 month. (4) Voluntarily participate in and comply with the clinical trial protocol, and sign a written subject informed consent. 2. Inclusion criteria for non-PKD CKD patients: (1) Age 18-80 years old, male or female. (2) Non-PKD CKD patients with no history of diagnosis of polycystic kidney disease. (3) No history of antibiotics or probiotics in the past 1 month. (4) Voluntarily participate in and comply with the clinical trial protocol, and sign a written subject informed consent. 3. Inclusion criteria of healthy control group: (1) Age 18-80 years old, male or female. (2) Healthy people without chronic kidney disease. (3) No history of antibiotics or probiotics in the past 1 month. (4) Voluntarily participate in and comply with the clinical trial protocol, and sign a written subject informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with advanced liver, heart, autoimmune diseases or a history of intra-abdominal surgery, small intestine or small bowel resection, small intestine obstruction, colon cancer or gastrointestinal bleeding; (2) Patients who received oral multivitamins, vitamin D analogues, probiotics, prebiotics, antibiotics, immunosuppressive drugs, steroids, or chemotherapy during the last 1 month prior to enrollment; (3) Patients who received intravenous or oral iron supplements, laxatives, or potassium lowering resin drugs in the last month before enrollment were excluded; (4) Patients who have undergone kidney transplantation; (5) severe cardiopulmonary dysfunction; (6) Patients with severe liver dysfunction; (7) Pregnant or lactating women; (8) Neurological or psychiatric disorders that hinder the effective implementation of informed consent or may interfere with subjects' compliance with research procedures (such as severe depression in the past 2 years, history of suicidal behavior in the past 3 months, etc.); (9) Those who did not sign the informed consent and/or the research process was not fully completed; (10) Patients with other factors deemed unsuitable for inclusion by the investigators (severe constipation or diarrhea).

Design outcomes

Primary

MeasureTime frame
Changes in gut microbiota composition;

Secondary

MeasureTime frame
Metabolomics analysis;

Countries

China

Contacts

Public ContactYang Shiming

The Second Affiliated Hospital of Army Medical University

383124847@qq.com+86 132 2868 6589

Outcome results

None listed

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