Probiotic Supplement as Treatment for Students With ADHD

Not Applicable

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT02908802
• Lead Sponsor: Tel Hai College

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.

Study Timeline

• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-21
• Study Start: 2016-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Probiotic capsules: two capsules twice a day
Placebo	Placebo	Probiotic capsules without the active ingredient: two capsules twice a day

Primary Outcome Measures

Name	Time	Method
Reduce symptoms of attention deficit measured by MOXO test	Six month	After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test