Attention Deficit Hyperactivity Disorder (ADHD)NCT02908802
Probiotic Supplement as Treatment for Students With ADHD
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Tel Hai College.
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… Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
About this study
Official title: A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read the 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.
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic
PlaceboDietary supplement
Probiotics capsules without the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic capsules: two capsules twice a day Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Probiotic capsules without the active ingredient: two capsules twice a day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snait Tamir, Professor, Study director, snait@telhai.ac.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908802
- Sponsor's protocol ID
- 40-16
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02908802
- Acronym / sponsor ID
- 40-16
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic capsules: two capsules twice a day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboProbiotic capsules without the active ingredient: two capsules twice a day |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic | Dietary supplement | Probiotic |
| PlaceboProbiotics capsules without the active ingredient | Dietary supplement | Placebo |
Primary outcome
Reduce symptoms of attention deficit measured by MOXO test
Time frame: Six month
After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snait Tamir, Professor study director
snait@telhai.ac.il
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Tel Hai College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce symptoms of attention deficit measured by MOXO test (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.