Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with ADHD
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Design
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Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive probiotic supplements (n=20) or placebo (n=20)
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Settings and conduct
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Among children with ADHD referred to Kargarnejad clinic affiliated to Kashan University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in packaging. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. intervention duration: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: children aged 8-12 years diagnosed with ADHD based on DSM-IV criteria will be included in this study. Exclusion criteria: mental disorders, bipolar disorder, pervasive developmental disorders, autism, not interested to be in research, consuming probiotic yogurt and other fermented foods, taking probiotic, antioxidant and/or anti-inflammatory supplements including vitamin E, vitamin C and omega-3 fatty acids, and taking antibiotics.
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Intervention groups
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Intervention group: probiotic sachet (Takgen Co., Tehran, 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 sachet (Takgen Co., Tehran, Iran), daily, for 8 weeks orally.
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Main outcome variables
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ADHD rating scale (primary outcome) and inflammatory factors, biomarkers of oxidative stress, depression and anxiety (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017090133941N16
Registration date:
2017-11-01, 1396/08/10
Registration timing:
retrospective
Last update:
2018-04-10, 1397/01/21
Update count:
2
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Registration date
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2017-11-01, 1396/08/10
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-06-05, 1396/03/15
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Expected recruitment end date
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2017-09-06, 1396/06/15
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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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Clinical trial of the effect of probiotic supplementation compared with the placebo on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder undergoing Ritalin treatment
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Public title
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Effect of probiotic supplementation in treatment of children with attention deficit hyperactivity disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children aged between 8 and 12 years
Patients diagnosed with attention deficit hyperactivity disorder based on DSM-IV criteria
Exclusion criteria:
mental disorders
bipolar disorder
pervasive developmental disorders
autism
not interested to be in research
consuming probiotic yogurt, kefir and other fermented foods
taking probiotic, antioxidant and/or anti-inflammatory supplements including vitamin E, vitamin C and omega-3 fatty acid
taking antibiotics
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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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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Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study 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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2016-09-27, 1395/07/06
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Ethics committee reference number
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IR.KAUMS.REC.1395.59
Health conditions studied
1
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Description of health condition studied
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Attention Deficit Hyperactivity Disorder
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ICD-10 code
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F90.0
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ICD-10 code description
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Disturbance of activity and attention
Primary outcomes
1
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Description
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ADHD rating scale
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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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Questionnaire
Secondary outcomes
1
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Description
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Hs-CRP
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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 kit
2
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Description
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Nitric oxide
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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
3
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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
4
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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
5
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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
6
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Description
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Hamilton Anxiety Rating scale
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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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Questionnaire
7
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Description
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depression
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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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Questionnaire
Intervention groups
1
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Description
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Intervention group: probiotic sachet (Takgen Company, Tehran, 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 sachet (Takgen Company, Tehran, Iran), daily, for 8 weeks orally.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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