Probiotic Supplement as Treatment for Students With ADHD

Tel Hai College

Status: Unknown

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02908802

40-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 19 to 30 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Probiotic capsules: two capsules twice a day

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo