The aim of this study is to determine the effects of probiotics supplementation on clinical outcomes and biomarkers of oxidative stress and inflammation in children with brucellosis.
Design
Clinical trial with placebo group, Parallel groups, double-blind, randomized
Settings and conduct
Among children with brucellosis referred to the pediatric clinic at Shahid Beheshti hospital affiliated to Kashan University of Medical Sciences, 50 patients will be selected according to inclusion and exclusion criteria. Children, their parents, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Blood samples will be taken at baseline and 8 weeks after the intervention. Intervention period: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 8-15 years, diagnosed with brucellosis. Exclusion criteria: Patients who are receiving any immunosuppressive drugs, children diagnosed with the acquired immunosuppressive disease, taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment.
Intervention groups
Intervention group: Probiotic capsule (Zisttakhmir Co., Iran) including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily for 8 weeks orally. Control group: Placebo capsule (Barij essence, Kashan, Iran), daily for 8 weeks orally.
Main outcome variables
Outcomes: Serum hs-CRP (primary outcome) and clinical outcomes, biomarkers of oxidative stress (secondary outcomes) will be quantified.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N65
Registration date:2019-10-14, 1398/07/22
Registration timing:registered_while_recruiting
Last update:2019-10-14, 1398/07/22
Update count:1
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-03, 1398/06/12
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of probiotics supplementation in the treatment of children with brucellosis
Public title
Probiotics and brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children diagnosed with brucellosis
Children aged 8-15 years
Exclusion criteria:
Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment.
Children diagnosed with acquired immunosuppressive disease
Patients who are receiving any immunosuppressive drugs.
Age
From 8 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 50 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Pediatric clinic of Shahid Beheshti Hospital, affiliated to Kashan University of Medical Science, who is not involved in the trial and not aware of random sequences, will assign the participants to intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.044
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Serum hs-CRP levels
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa
Secondary outcomes
1
Description
Fever duration
Timepoint
After intervention
Method of measurement
Checklist
2
Description
Chills duration
Timepoint
After intervention
Method of measurement
Checklist
3
Description
Sweating duration
Timepoint
After intervention
Method of measurement
Checklist
4
Description
Arthritis duration
Timepoint
After intervention
Method of measurement
Checklist
5
Description
Arthralgia duration
Timepoint
After intervention
Method of measurement
Checklist
6
Description
Myalgia duration
Timepoint
After intervention
Method of measurement
Checklist
7
Description
Anorexia duration
Timepoint
After intervention
Method of measurement
Checklist
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention