Clinical trial NCT02908802: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduce symptoms of attention deficit measured by MOXO test
timeFrame: Six month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: snait@telhai.ac.il
name: Snait Tamir, Professor
role: STUDY_DIRECTOR
References: