Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT02908802
Status:
UNKNOWN
Last Update Posted:
2018-09-12
First Post:
2016-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Supplement as Treatment for Students With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2016-09-18', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce symptoms of attention deficit measured by MOXO test', 'timeFrame': 'Six month', 'description': 'After six month of treatment reduce symptoms of attention deficit will be measured by MOXO test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder (ADHD)']}, 'descriptionModule': {'briefSummary': 'Subjects will answer the following questionnaire and tests:\n\n* Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)\n* Demographic Questionnaire - composed by the researchers\n* Family Eating Habits Questionnaire (FEAHQ-33)\n* Food Frequency Questionnaire (FFQ)\n* Test MOXO\n\nThe subjects will take the study product for six months.\n\nAfter six months the subject will fill once again all the questionnaires.', 'detailedDescription': "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.\n\nSubjects will answer the following questionnaire and tests:\n\n* Symptom severity and improvement will be measured using ADHA Rating scale IV (ADHD RS)\n* Demographic Questionnaire - composed by the researchers\n* Family Eating Habits Questionnaire (FEAHQ-33)\n* Food Frequency Questionnaire (FFQ)\n* Test MOXO\n\nThe subjects will take the study product for six months.\n\nAfter six months the subject will fill once again all the questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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,\n* Students who are not treated by medication or alternative treatment,\n* Students who are not due to complete their education at Tel Hai College during the study period,\n* Students who have signed on an informed consent form,\n* No dairy intolerance (student can consume milk without any adverse effects),\n* No soy allergy,\n* Not currently taking any antibiotics or probiotics,\n* Not pregnant or planning to become pregnant during the study period,\n* Not been diagnosed with any of the following:\n\n * Cancer\n * HIV/AIDS\n * Crohn's disease\n * Ulcerative colitis\n * Immune compromised illness\n * Other serious illness\n\nExclusion Criteria:\n\n* Students treated by any type of treatment for Attention Deficit Hyperactivity Disorder,\n* Students who have not been assessed by MATAL and a psychiatrist,\n* Students who take antibiotics."}, 'identificationModule': {'nctId': 'NCT02908802', 'briefTitle': 'Probiotic Supplement as Treatment for Students With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Tel Hai College'}, 'officialTitle': 'A Double-Blind Placebo Controlled Study of Probiotic Supplement as Treatment for Students With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': '40-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'Probiotic capsules: two capsules twice a day', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Probiotic capsules without the active ingredient: two capsules twice a day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics capsules without the active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Snait Tamir, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'snait@telhai.ac.il'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Hai College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}