A clinical trial to investigate the effects of probiotic supplementation on the amount of urine oxalate in patients with recurrent calcium kidney stones
- Conditions
- Calcium kidney stone.Calculus of kidney
- Registration Number
- IRCT2016020626406N1
- Lead Sponsor
- ational Institute for Medical Research Developement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
Patients with a history of at least 2 times of calcium (radiopaque) kidney stone episodes in recent 25 months (Recurrent stone former); at least 20 days since the last treatment they have; at least 3 months since following general dietary advice on recurrence prevention (drinking advice, high oxalate food restriction, animal protein restriction, fruit and vegetable intake encouragement, salt restriction and fat intake modification); age 18 to 65 years; Hyperoxaluria (24-hour urine oxalate over 40 and less than 80 mg); willingness to cooperate in the study.
Exclusion criteria:
Primary or enteric hyperoxaluria (urine oxalate>80 mg/24h); Taking any drugs which affects calcium metabolism, including thiazides; Taking any drugs which affects oxalate metabolism or calcium oxalate supersaturation, including vitamin B6; History of diabetes mellitus, hepatic failure, thyroid or parathyroid diseases, chronic kiodney disease (CKD), Urinary tract infection (UTI), chronic diarrhea or immunologic diseases; Pregnancy or lactation
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 24 hour urine oxalate. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after intervention. Method of measurement: Enzymatic method.;Calcium oxalate supersaturation. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after intervention. Method of measurement: Calculation by LITHORISK software.
- Secondary Outcome Measures
Name Time Method Stool oxalate. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after intervention. Method of measurement: Enzymatic method.;Stool lactobacillus count. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after intervention. Method of measurement: real-time PCR.;Stool bifidobacter count. Timepoint: Before the intervention, 4 weeks after the intervention, 8 weeks after intervention. Method of measurement: real-time PCR.