Evaluation of the effectiveness of probiotic( lactobacillus reuteri )on the course of the disease and response to treatment of children with nephrotic syndrome.
Determining the effect of probiotics in the treatment of children with nephrotic syndrome
Design
All children aged 2 to 14 years who are referred to the pediatric nephrology clinic of Besat Hospital with a diagnosis of idiopathic nephrotic syndrome are randomly divided into two groups. The first group is treated classically, the second group is treated with probiotics.
Settings and conduct
This one-year research will take place at Besat Hospital's nephrology clinic in Hamadan.After taking the history, physical examination, routine tests and necessary imaging examinations and grouping of patients, the protocols will be implemented.
Participants/Inclusion and exclusion criteria
All children aged 2 to 14 years who are diagnosed with idiopathic nephrotic syndrome are referred to the pediatric nephrology clinic of Besat Hospital and their disease is confirmed by a pediatric nephrologist based on the above criteria. Association with glomerulonephritis (nephrotic nephrotic syndrome) association with renal failure and with hypertension , initiation of antibiotics for any reason, age less than 2 years and more than 14 years and dissatisfaction to participate are excluded from the study
Intervention groups
probiotic is administered orally from rotflore sachet (containing 10 to 8 rotary lactobacilli per sachet) daily
Main outcome variables
Outcome of the disease is defined as recurrence of the disease (proteinuria) or non-recurrence and the course of the disease in terms of response to treatment and the rate of recurrence within 1 year.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210620051628N1
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Golamreza Kalvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3253 3254
Email address
g.kalvandi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of probiotic( lactobacillus reuteri )on the course of the disease and response to treatment of children with nephrotic syndrome.
Public title
Evaluation of the effect of probiotic prophylaxis in children with nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children 2 to 14 years old who are diagnosed with idiopathic nephrotic syndrome are referred to the pediatric nephrology clinic of Besat Hospital and their disease is approved by a pediatric nephrologist based on diagnostic criteria.
Exclusion criteria:
congenital nephrotic syndrome
Secondary nephrotic syndrome
Associated with glomerulonephritis (nephrotic nephrotic syndrome)
Accompanied by kidney failure
Accompanied by high blood pressure
Start antibiotics for any reason
Age less than 2 years and more than 14 years
Dissatisfaction
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Alternative block randomization method was used.
Random units were children with nephrotic syndrome.
R statistical software will be used to generate randomized blocks in this clinical trial. In this software, Blockrand () function was used for random allocation.
Using this function, random designs are generated and individuals are assigned to the treatment or control group based on the blocks produced. For example, in the quadruple block of ABAB, the first and third patients to group A, and the second and fourth patients to treatment B. Are allocated.
In this study, 12 blocks of 4 will be used. [We have shown the classical therapy group with the symbol "B" and the probiotic therapy group with the symbol "A"]
Blinding (investigator's opinion)
Single blinded
Blinding description
The control group is treated with prednisone. The prednisone and probiotic treatment group, which is similar in structure, shape, color, and odor to the control group, and the drugs are indistinguishable in appearance.
Due to the fact that patients are randomly assigned to groups, patients are not aware of the assigned treatment.
In this study, participants enter the study based on designated blocks and without knowing the placement in groups. Patients are unaware of being placed in groups, but the facilitator (researcher) is aware of how to place and group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.UMSHA.REC.1400.308
Health conditions studied
1
Description of health condition studied
nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Follow-up of relapse and treatment of patients
Timepoint
MONTHLY
Method of measurement
Presence or absence of proteinuria
Secondary outcomes
1
Description
Recurrence of nephrotic syndrome in treated patients
Timepoint
En MONTHLY
Method of measurement
Presence of protein in urine
Intervention groups
1
Description
Intervention group:probiotic is administered orally from rotflore sachet (containing 10 to 8 rotary lactobacilli per sachet) daily
Category
Prevention
2
Description
Control group: In this group, patients with idiopathic nephrotic syndrome are treated only with classical treatment includes prednisone from Iran Hormone Pharmaceutical Company ,60mg/m2/day