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
Objectives :Determine 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
Design: Double blind Randomized Clinical trial (blinded for patients and researchers)
Setting and conduct:
1- Evaluation of the ability to degrade oxalate in strains listed in title plus available species (including lactobacillus and Bifidobacterium spp.) and selection of best strains
2- Preparation of a probiotic supplement from selected strains
3- Patient enrollment and assessment of 24-hour urine oxalate and supersaturation of calcium oxalate, examining stool samples by real time PCR to investigate the colonization of selected bacteria, assessment of fecal oxalate (sample size: 55 patients in each group)
4- Intervention (4 weeks)
5- Repeat step 3
6- 4-week washout
7- Repeat step 3 for final assessment
Major Inclusion and Exclusion criteria
Inclusion criteria:
Recurrent calcium stone former; Age 18-65 years; Hyperoxaluria (24 h urine oxalate >40 mg/24h)
Exclusion criteria:
Primary or enteric hyperoxaluria (urine oxalate>80 mg/24h); Taking any drugs which affect 24 hour urine calcium, oxalate or supersaturation; History of any confounding chronic disease including and Urinary tract infection
Intervention: Consuming probiotic supplement or placebo
Main outcome measures (variables): 24 hour urine oxalate and calcium oxalate supersaturation
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016020626406N1
Registration date:2016-06-15, 1395/03/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Sanaz Tavasoli
Name of organization / entity
Urology and Nephrology Research Center,Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
s.tavasoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
1- National Institute for medical research development
2- Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
A clinical trial to investigate the effects of probiotic supplementation on the amount of urine oxalate in patients with recurrent calcium kidney stones
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sc
Street address
No 103, 9th Boustan St., Pasdaran Ave
City
Tehran
Postal code
Approval date
2016-06-07, 1395/03/18
Ethics committee reference number
IR.SBMU.UNRC.1395.3
Health conditions studied
1
Description of health condition studied
Calcium kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
24 hour urine oxalate
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
Enzymatic method
2
Description
Calcium oxalate supersaturation
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
Calculation by LITHORISK software
Secondary outcomes
1
Description
Stool oxalate
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
Enzymatic method
2
Description
Stool lactobacillus count
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
real-time PCR
3
Description
Stool bifidobacter count
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
real-time PCR
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: Patients taking placebo. Place of placebo production: Iranian society of probiotic and functional foods. Duration and Dosage: One daily for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Stone prevention clinic- Labafinejad hospital - Urology and Nephrology Research Center
Full name of responsible person
Sanaz Tavasoli
Street address
No 103, 9th Boustan St., Pasdaran Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Developement
Full name of responsible person
Non-communicable diseases commitee
Street address
Between Gharib and Eskandari St., Azadi Ave.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Developement
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Urology and Nephrology Research Center
Full name of responsible person
Shabnam Golshan
Street address
No 103, 9th Boustan St., Pasdaran Ave.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urology and Nephrology Research Center
Full name of responsible person
Sanaz Tavasoli
Position
Assistant Professor
Other areas of specialty/work
Street address
No 103, 9th Boustan. St., Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2256 7222
Fax
Email
s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology and Nephrology Research Center
Full name of responsible person
Sanaz Tavasoli
Position
Associate Professor
Other areas of specialty/work
Street address
No 103, 9th Boustan St., Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2256 7222
Fax
Email
s.tavasoli@sbmu.ac.ir; sanaz.tavasoli@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology and Nephrology Research Center
Full name of responsible person
Sanaz Tavasoli
Position
Associate Professor
Other areas of specialty/work
Street address
No 103, 9th Boustan St., Pasdaran Ave.
City
Tehran
Postal code
Phone
+98 21 2256 7222
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)