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Probiotic Supplement as Treatment for Students With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Tel Hai College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

19 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Probiotic

    Placebo

    Arm Description

    Probiotic capsules: two capsules twice a day

    Probiotic capsules without the active ingredient: two capsules twice a day

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2016
    Last Updated
    September 11, 2018
    Sponsor
    Tel Hai College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02908802
    Brief Title
    Probiotic Supplement as Treatment for Students With ADHD
    Official Title
    A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel Hai College

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder (ADHD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Active Comparator
    Arm Description
    Probiotic capsules: two capsules twice a day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Probiotic capsules without the active ingredient: two capsules twice a day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic
    Intervention Description
    Probiotic
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Probiotics capsules without the active ingredient
    Primary Outcome Measure Information:
    Title
    Reduce symptoms of attention deficit measured by MOXO test
    Description
    After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test
    Time Frame
    Six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Snait Tamir, Professor
    Organizational Affiliation
    snait@telhai.ac.il
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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