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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016020626406N1
Enrollment
110
Registered
2016-06-15
Start date
2016-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Calcium kidney stone. Calculus of kidney

Interventions

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. Dur
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
Control group: Patients taking placebo. Place of placebo production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks

Sponsors

National Institute for Medical Research Developement
Lead Sponsor
Urology and Nephrology Research Center
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSanaz Tavasoli

Urology and Nephrology Research Center

s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com+98 21 2256 7222

Outcome results

None listed

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