Probiotic Supplement as Treatment for Students With ADHD

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02908802
• Other study ID #: 40-16
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Tel Hai College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Dietary Supplement:
• Probiotic
Probiotic
• Placebo
Probiotics capsules without the active ingredient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel Hai College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce symptoms of attention deficit measured by MOXO test	After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test	Six month