Probiotic Supplement as Treatment for Students With ADHD

NCT02908802 | Unknown

• 1 other identifier: 40-16
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic capsules: two capsules twice a day

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic

Probiotic

Placebo DIETARY_SUPPLEMENT

Probiotics capsules without the active ingredient

Placebo

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Hai College: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Snait Tamir, Professor

  snait@telhai.ac.il

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share