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IRCT2016020626406N1 IRCT 2016-06-15 National Institute for Medical Research Developement A clinical trial to investigate the effects of probiotic supplementation on the amount of urine oxalate in patients with recurrent calcium kidney stones - Evaluating the effect of a probiotic supplement including Lactobacillus and Bifidiobacterium (with emphasis on the strains of Lactobacillus acidophilus LA14 and NCFM, Lactobacillus gasseri and Bifidiobacterium lactis BI07) on 24 hour urine oxalate and calcium oxalate supersaturation in recurrent calcium stone patients with hyperoxaluria: a randomized clinical trial 2016-10-22 anticipated 110 Complete https://irct.ir/trial/21898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: 1- Preparation of strains listed in title plus available species (including lactobacillus and Bifidobacterium spp.) 2- Evaluation of the ability to degrade oxalate (before and after treatment of strains with oxalate in order to increase the expression of oxalate degrading enzymes) and selection of best conditions for the treatment of strains 3- Preparation of a probiotic supplement from selected strains Randomization method: Blocked randomization. N/A Calcium kidney stone. Intervention 1: Intervention group: Patients taking probiotic supplement made from strains selected in the study. Place of supplement production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks. Intervention 2: Control group: Patients taking placebo. Place of placebo production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks.
public Sanaz Tavasoli
No 103, 9th Boustan. St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 7222 s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com Urology and Nephrology Research Center scientific Sanaz Tavasoli
No 103, 9th Boustan St., Pasdaran Ave.
Tehran Iran (Islamic Republic of) +98 21 2256 7222 s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com Urology and Nephrology Research Center Iran (Islamic Republic of) 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 18 years 65 years Both N20.0 Calculus of kidney Treatment - Drugs Placebo Intervention group: Patients taking probiotic supplement made from strains selected in the study. Place of supplement production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks. Control group: Patients taking placebo. Place of placebo production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks 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. 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. Urology and Nephrology Research Center National Institute for Medical Research Developement Urology and Nephrology Research Center Approved 2016-06-07 Ethics committee of Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sc No 103, 9th Boustan St., Pasdaran Ave Tehran Iran (Islamic Republic of)