Nctid:
NCT06226584
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001289", "term"=>"Attention Deficit Disorder with Hyperactivity"}], "ancestors"=>[{"id"=>"D000019958", "term"=>"Attention Deficit and Disruptive Behavior Disorders"}, {"id"=>"D000065886", "term"=>"Neurodevelopmental Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M9999", "name"=>"Hyperkinesis", "relevance"=>"LOW"}, {"id"=>"M4594", "name"=>"Attention Deficit Disorder with Hyperactivity", "asFound"=>"Hyperactivity Disorder", "relevance"=>"HIGH"}, {"id"=>"M21830", "name"=>"Attention Deficit and Disruptive Behavior Disorders", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-03", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-11-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-13", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-11-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The Swanson, Nolan and Pelham Chinese (SNAP) rating scales", "timeFrame"=>"every one month for 3 months", "description"=>"for behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome"}, {"measure"=>"Conners' Continuous Performance Test 3rd Edition", "timeFrame"=>"pre- and post-intervention (3 months)", "description"=>"a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older"}, {"measure"=>"quantitative electroencephalogram", "timeFrame"=>"pre- and post-intervention (3 months)", "description"=>"measurement of brain wave patterns and coherence"}], "secondaryOutcomes"=>[{"measure"=>"adverse events", "timeFrame"=>"every one month for 3 months", "description"=>"any adverse events occurred during study"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["ADHD", "probiotics", "quantitative electroencephalogram"], "conditions"=>["Attention Deficit and Hyperactivity Disorders"]}, "descriptionModule"=>{"briefSummary"=>"Probiotics are widely used as supplement for various neurodevelopmental disorders. The mechanism of their therapeutic potential lies in the \"gut-brain axis\", a two-way communication pathway through the neuroendocrine system. In the past, there have been many experiments to study the possible efficacy of probiotics in patients with ADHD. Although some studies have shown that probiotics can improve ADHD symptoms, most studies have used behavioral rating scales to evaluate. As a result, it is susceptible to informant bias. Standardized attentional tests and quantitative electroencephalogram (qEEG) can provide more objective data and detect possible changes in brain networks. Such changes may precede behavioral phenotypes. Therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qEEG)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"11 years", "minimumAge"=>"8 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nA patient is eligible for the study if all of the followings apply:\n\n1. 8-11 children diagnosed with ADHD by board certified pediatric psychiatrist according to DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation)\n2. On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks\n\nExclusion Criteria:\n\nAny patient meeting any of the exclusion criteria will be excluded from study participation:\n\n1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.\n2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.\n3. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.\n4. Participated in other clinical research in the past month.\n5. Vegetarians or those currently undergoing special diet therapy.\n6. Evaluation by the pediatric psychiatrist not suitable for entering the test"}, "identificationModule"=>{"nctId"=>"NCT06226584", "briefTitle"=>"Multi-strain Probiotics for ADHD", "organization"=>{"class"=>"OTHER", "fullName"=>"Tsyr-Huey Mental Hospital"}, "officialTitle"=>"Therapeutic Effects of Multiple-strain Probiotics for Children With ADHD Based on Assessment of Standardized Attention Tests and Quantitative Electroencephalogram: a Single Arm Pilot Study", "orgStudyIdInfo"=>{"id"=>"MultiProbioADHD"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"multiple-strain probiotics", "interventionNames"=>["Dietary Supplement: multiple-strain probiotics"]}], "interventions"=>[{"name"=>"multiple-strain probiotics", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Juice HA capsule which contains more than one strain of probiotics", "armGroupLabels"=>["multiple-strain probiotics"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"831", "city"=>"Kaohsiung", "status"=>"RECRUITING", "country"=>"Taiwan", "contacts"=>[{"name"=>"YU-SHIAN CHENG, MDPhD", "role"=>"CONTACT", "email"=>"n043283@gmail.com", "phone"=>"00886987173901"}, {"name"=>"YU-SHIAN CHENG, MDPhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Tsyr-HueyMentalHospital", "geoPoint"=>{"lat"=>22.61626, "lon"=>120.31333}}], "centralContacts"=>[{"name"=>"YU-SHIAN CHENG, MDPhD", "role"=>"CONTACT", "email"=>"n043283@gmail.com", "phone"=>"00886978173901"}], "overallOfficials"=>[{"name"=>"YU-SHIAN CHENG, MDPhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Tsyr-Huey Mental Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tsyr-Huey Mental Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Psychiatrist", "investigatorFullName"=>"Cheng Yu-Shian", "investigatorAffiliation"=>"Tsyr-Huey Mental Hospital"}}}}
