Probiotic Supplement as Treatment for Students With ADHD

September 11, 2018 updated by: Tel Hai College

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
Probiotic capsules: two capsules twice a day
Dietary supplement: Probiotic
Probiotic
Placebo Comparator: Placebo
Probiotic capsules without the active ingredient: two capsules twice a day
Dietary supplement: Placebo
Probiotics capsules without the active ingredient

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Hai College

Investigators

  • Study Director: Snait Tamir, Professor, snait@telhai.ac.il

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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