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A clinical trial to investigate the effects of probiotic supplementation on the amount of urine oxalate in patients with recurrent calcium kidney stones

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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.
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