Autosomal dominant polycystic kidney disease, ADPKD
Conditions
Interventions
Placebo:Powdered control matched with probiotics
Powdered control matched with probiotics
Powdered control matched with probiotics, take 1 sachet orally per day.
Probiotic :Bifidobacterium animalis subsp. lactis R7970, take 1 sachet orally per day.
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old; (2) meeting the diagnostic criteria of polycystic kidney disease (ADPKD) (1. Ultrasound diagnosis: 18 to 39 years old with unilateral/bilateral renal cysts =3; 40-59 years old, =2 renal cysts on each side; =60 years old, =4 renal cysts on each side; MRI diagnosis: the total number of renal cysts was =10; 2. A clear family history of ADPKD; (3) PKD1 or PKD2 mutation in at least one member of the family); (3) CKD1-4 stage, no dialysis treatment, no dialysis indication, temporarily stable condition, drug can control stage; (4) Men of childbearing age and women of childbearing age should use effective contraceptive methods after signing the informed consent until the end of the safety follow-up period; (5) signed the informed consent, understood and agreed to comply with the requirements of the study and the trial process arrangement.
Exclusion criteria
Exclusion criteria: (1) pregnant or lactating patients; (2) female patients who did not use any contraceptive measures; (3) patients with unstable vital signs and unstable conditions; (4) patients with urgent dialysis indications such as hyperkalemia and heart failure that are difficult to correct; (5) Those who could not be controlled by medical conservative treatment but still had one of the following conditions were excluded: Hb 5.5 mmol/L; Or high serum creatinine, eGFR = 5 ml/min·1.73 m2 (estimated by EPI formula); (6) patients with diabetes mellitus, other major renal diseases (such as various primary and secondary renal diseases), renal malignant tumors, single kidney, recent renal surgery or acute kidney injury; (7) patients taking drugs that may affect the growth of ADPKD cysts (including but not limited to tolvaptan, metformin, somatostatin, tyrosine kinase inhibitor, pravastatin, etc.); (8) complicated with active malignant tumor, cerebral infarction, cerebral hemorrhage, myocardial infarction and other serious primary diseases; (9) History of gastrointestinal diseases such as gastrointestinal bleeding, irritable bowel syndrome, Crohn's disease or ulcerative colitis, and history of gastrointestinal surgery; (10) history of psychosis; (11) with polycystic kidney serious complications: such as polycystic kidney infection, bleeding, or for the diameter of the cyst is greater than 5cm, or the recent volume increased significantly, the cyst compression, hydronephrosis symptoms; (12) patients with a history of kidney transplantation or planning to receive kidney transplantation within 6 months; (13) taking antibiotics, glucocorticoids or other immunosuppressive agents, foods or drugs containing probiotics/prebiotics in the past 1 month; (14) recipients who were allergic to the test sample or had obvious gastrointestinal symptoms such as intolerance; (15) patients unable to undergo MRI examination; (16) patients receiving other clinical trials at the same time; (17) Failure to complete the study on time as determined by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| renal total volume measurement;Creatinine;Urea nitrogen;High-sensitivity C-reactive protein;Hemoglobin;albumin;Prealbumin;Parathyroid hormone;Urinary albumin-to-creatinine ratio;24-hour urinary protein;Detection of gut microbiota;Fecal metabolomics testing; | — |
Countries
China
Contacts
Public ContactYing Yao
Department of Nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed