Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Probiotics, Children
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Attention Deficit Hyperactivity Disorder
- Having an Intelligence quotient more than 85 based on Wechsler test for children
- Willing to participate in the study
Exclusion Criteria:
- History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
- Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
- History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
Sites / Locations
- National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
The probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophilus PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium longum PXN 30, Lactobacillus bulgaricus PXN 39)
Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.
Outcomes
Primary Outcome Measures
symptoms of Attention-deficit hyperactivity disorder (ADHD)
symptoms were assessed using Conners's scale
The severity of the Attention-deficit hyperactivity disorder (ADHD)
The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test
Secondary Outcome Measures
Full Information
NCT ID
NCT04333394
First Posted
March 24, 2020
Last Updated
April 1, 2020
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT04333394
Brief Title
Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
Official Title
Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating
Detailed Description
Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Probiotics, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study will be conducted as a phase 3, randomized double-blind placebo-controlled trial on 40 attention deficit hyperactivity disorder patients allocated in 2 parallel groups each consisted of 20 patients who will receive Probiotic or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using ten 4-Block Randomization.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both patients and researchers won't be aware of the treatments patients receiving in this study (unaware of the quiddity of A and B capsules), so the study has a double-blind design. Only one of the staff of the company that supplied the Probiotic supplement is aware of the type of assigned intervention for each patient. After collecting the data, he will unseal the codes for researchers, the statistical analyst, participants and those who prepare the manuscript.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
The probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophilus PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium longum PXN 30, Lactobacillus bulgaricus PXN 39)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The probiotic capsules will be administrated once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with probiotic supplementation.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules will be administered once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with placebo supplementation.
Primary Outcome Measure Information:
Title
symptoms of Attention-deficit hyperactivity disorder (ADHD)
Description
symptoms were assessed using Conners's scale
Time Frame
8 weeks
Title
The severity of the Attention-deficit hyperactivity disorder (ADHD)
Description
The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Attention Deficit Hyperactivity Disorder
Having an Intelligence quotient more than 85 based on Wechsler test for children
Willing to participate in the study
Exclusion Criteria:
History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hekmatdoost, MD.PhD
Phone
2122357484
Email
a_hekmat2000@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hekmatdoost
Email
a_hekmat2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soodeh Razeghi Jahromi, PhD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehrān
State/Province
Tehran
ZIP/Postal Code
19395-4741
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
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