Probiotic Supplement as Treatment for Students With ADHD

NCT ID: NCT02908802

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-10-31

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic

Probiotic capsules: two capsules twice a day

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Probiotics capsules without the active ingredient

Interventions

Probiotic

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Probiotics capsules without the active ingredient

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel Hai College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Snait Tamir, Professor

Role: STUDY_DIRECTOR

snait@telhai.ac.il

Other Identifiers

40-16

Identifier Type: -

Identifier Source: org_study_id