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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Protocol summary
Objective: The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder (ADHD).
The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with ADHD
Objective: The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder (ADHD).
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. At the beginning and the end of the intervention: 8 weeks.
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.
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. At the beginning and the end of the intervention duration: 8 weeks.
Inclusion criteria: children aged 8-12 years diagnosed with ADHD based on DSM-IV criteria will be included in this study. Exclusion criteria: Unwillingness to cooperate.
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.
Inclusion criteria: children aged 8-12 years diagnosed with ADHD based on DSM-IV criteria will be included in this study. Exclusion criteria: Unwillingnessmental disorders, bipolar disorder, pervasive developmental disorders, autism, not interested to cooperatebe 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.
معیار ورود به مطالعه: کودکان 12-8 ساله با تشخیص اختلال کم توجهی-بیش فعالی بر اساس کرایتریای DSM-IV. معیارهای خروج مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: کودکان 12-8 ساله با تشخیص اختلال کم توجهی-بیش فعالی بر اساس کرایتریای DSM-IV. معیارهای خروج مطالعه: اختلالات ذهنی، اختلال دو قطبی، اختلالات نافذ رشد، اوتیسم، عدم تمایل به همکاری، مصرف ماست پروبیوتیک و سایر فراورده های حاوی پروبیوتیک، مصرف هرگونه مکمل دارای خواص آنتی اکسیدانی و ضد التهابی از قبیل ویتامین E، ویتامین C، اسیدهای چرب امگا-3 و پروبیوتیک و مصزف آنتی بیوتیک.
معیار ورود به مطالعه: کودکان 12-8 ساله با تشخیص اختلال کم توجهی-بیش فعالی بر اساس کرایتریای DSM-IV. معیارهای خروج مطالعه: اختلالات ذهنی، اختلال دو قطبی، اختلالات نافذ رشد، اوتیسم، عدم تمایل به همکاری، مصرف ماست پروبیوتیک و سایر فراورده های حاوی پروبیوتیک، مصرف هرگونه مکمل دارای خواص آنتی اکسیدانی و ضد التهابی از قبیل ویتامین E، ویتامین C، اسیدهای چرب امگا-3 و پروبیوتیک و مصزف آنتی بیوتیک.
Intervention group: probiotic sachet 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 (Barij essence, Kashan, Iran), daily, for 8 weeks orally.
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.
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 (Barij essenceTakgen Co., KashanTehran, Iran), daily, for 8 weeks orally.
گروه مداخله: ساشه پروبیوتیک (زیست تخمیر، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: ساشه پلاسبو (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: ساشه پروبیوتیک (شرکت تک ژن، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: ساشه پلاسبو (شرکت تک ژن، تهران، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: ساشه پروبیوتیک (زیست تخمیرشرکت تک ژن، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: ساشه پلاسبو (باریج اسانسشرکت تک ژن، کاشانتهران، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
Outcomes: 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.
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.
Outcomes: 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
Unwillingness to cooperate.
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
Unwillingnessmental disorders bipolar disorder pervasive developmental disorders autism not interested to cooperate.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
عدم تمایل به همکاری.
اختلالات ذهنی
اختلال دو قطبی
اختلالات نافذ رشد
اوتیسم
عدم تمایل به همکاری
مصرف ماست پروبیوتیک و سایر فراورده های حاوی پروبیوتیک
مصرف هرگونه مکمل دارای خواص آنتی اکسیدانی و ضد التهابی از قبیل ویتامین E، ویتامین C، اسیدهای چرب امگا-3 و پروبیوتیک
مصزف آنتی بیوتیک
اختلالات ذهنی اختلال دو قطبی اختلالات نافذ رشد اوتیسم عدم تمایل به همکاری. مصرف ماست پروبیوتیک و سایر فراورده های حاوی پروبیوتیک مصرف هرگونه مکمل دارای خواص آنتی اکسیدانی و ضد التهابی از قبیل ویتامین E، ویتامین C، اسیدهای چرب امگا-3 و پروبیوتیک مصزف آنتی بیوتیک
گروه مداخله: ساشه پروبیوتیک (زیست تخمیر، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: ساشه پروبیوتیک (شرکت تک ژن، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: ساشه پروبیوتیک (زیست تخمیرشرکت تک ژن، تهران، ایران) شامل لاکتوباسیلوس اسیدوفیلوس 109×2، بیفیدوباکتریوم بیفیدوس 109×2، لاکتوفیلوس روتری 109×2، لاکتوباسیلوس فرمنتوم 109×2، روزانه، به صورت خوراکی برای 8 هفته.
#2
Control group: Placebo sachet (Barij essence, Kashan, Iran), daily, for 8 weeks orally.
Control group: Placebo sachet (Takgen Company, Tehran, Iran), daily, for 8 weeks orally.
Control group: Placebo sachet (Barij essenceTakgen Company, KashanTehran, Iran), daily, for 8 weeks orally.
گروه کنترل: ساشه پلاسبو (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
گروه کنترل: ساشه پلاسبو (شرکت تک ژن، تهران، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
گروه کنترل: ساشه پلاسبو (باریج اسانسشرکت تک ژن، کاشانتهران، ایران)، روزانه، به صورت خوراکی برای 8 هفته.
Protocol summary
Study aim
The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in children with ADHD
Design
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)
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
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
Registration date
2017-11-01, 1396/08/10
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
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of probiotic supplementation in treatment of children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study 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
8115187159
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.KAUMS.REC.1395.59
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
ADHD rating scale
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Hamilton Anxiety Rating scale
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire
7
Description
depression
Timepoint
At the beginning of the study and after 8 weeks of intervention