Probiotic Supplement as Treatment for Students With ADHD

Study Overview
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Brief Summary
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Subjects will answer the following questionnaire and tests: Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS) Demographic Questionnaire - composed by the researchers Family Eating Habits Questionnaire (FEAHQ-33) Food Frequency Questionnaire (FFQ) Test MOXO The subjects will take the study product for six months. After six months the subject will fill once again all the questionnaires.

Detailed Description
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Computerized performance test MOXO - the test has been developed in Israel by Neurotech Company. The test's goal is to assess and define a participant's performance according to the four indices of Attention Deficit Hyperactivity Disorder: Attention, Hyperactivity, Impulsivity, and Timing with adjustment for age. Subjects will answer the following questionnaire and tests: Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS) Demographic Questionnaire - composed by the researchers Family Eating Habits Questionnaire (FEAHQ-33) Food Frequency Questionnaire (FFQ) Test MOXO The subjects will take the study product for six months. After six months the subject will fill once again all the questionnaires.

Official Title
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A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students registered in the college's Support Center for Students with Learning Disabilities and who have been diagnosed by a computerized didactic assessment -MATAL - as well as an attention diagnosis by a psychiatrist or a neurologist, Students who are not treated by medication or alternative treatment, Students who are not due to complete their education at Tel Hai College during the study period, Students who have signed on an informed consent form, No dairy intolerance (student can consume milk without any adverse effects), No soy allergy, Not currently taking any antibiotics or probiotics, Not pregnant or planning to become pregnant during the study period, Not been diagnosed with any of the following: Cancer HIV/AIDS Crohn's disease Ulcerative colitis Immune compromised illness Other serious illness Exclusion Criteria: Students treated by any type of treatment for Attention Deficit Hyperactivity Disorder, Students who have not been assessed by MATAL and a psychiatrist, Students who take antibiotics.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Probiotic capsules: two capsules twice a day | Dietary Supplement: Probiotic<br>* Probiotic<br>|
| Placebo Comparator: Placebo<br>Probiotic capsules without the active ingredient: two capsules twice a day | Dietary Supplement: Placebo<br>* Probiotics capsules without the active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce symptoms of attention deficit measured by MOXO test | After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test | Six month |