Protocol summary
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Study aim
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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.
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Design
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Clinical trial with placebo group, Parallel groups, double-blind, randomized
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Settings and conduct
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Among children with brucellosis referred to the pediatric clinic at Shahid Beheshti hospital affiliated to Kashan University of Medical Sciences, 40 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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Outcomes: Serum hs-CRP (primary outcome) and clinical outcomes, biomarkers of oxidative stress (secondary outcomes) will be quantified.
General information
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Reason for update
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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N65
Registration date:
2019-10-14, 1398/07/22
Registration timing:
registered_while_recruiting
Last update:
2022-05-23, 1401/03/02
Update count:
1
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Registration date
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2019-10-14, 1398/07/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-03, 1398/06/12
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Expected recruitment end date
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2022-02-17, 1400/11/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of probiotics supplementation in the treatment of children with brucellosis
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Public title
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Probiotics and brucellosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 8 years old to 15 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-02, 1398/06/11
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1398.044
Health conditions studied
1
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Description of health condition studied
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Brucellosis
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ICD-10 code
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A23
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ICD-10 code description
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Brucellosis
Primary outcomes
1
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Description
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Serum hs-CRP levels
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Fever duration
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Timepoint
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After intervention
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Method of measurement
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Checklist
2
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Description
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Chills duration
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Timepoint
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After intervention
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Method of measurement
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Checklist
3
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Description
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Sweating duration
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Timepoint
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After intervention
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Method of measurement
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Checklist
4
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Description
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Musculoskeletal pain
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Timepoint
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After intervention
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Method of measurement
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Checklist
5
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Description
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Anorexia duration
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Timepoint
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After intervention
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Method of measurement
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Checklist
6
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule (Barij essence, Kashan, Iran), daily for 8 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available