Probiotic Supplement as Treatment for Students With ADHD | NCT02908802

Studies
Probiotic Supplement as Treatment for Students With ADHD

NCT02908802

Sponsor

Tel Hai College

Status

Unknown status

Last Update Posted

Sep 12, 2018Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Probiotic
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Sep 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Sep 18, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2018

Last Update Posted Date

Sep 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Probiotic	Probiotic
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena