Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:02 AM
Study NCT ID:
NCT07419659
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-27
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)', 'timeFrame': 'Baseline, 8th week and 12th week', 'description': "The SNAP-IV is used assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress."}, {'measure': 'Total Scores of Child Behavior Checklist', 'timeFrame': 'Baseline, 8th week and 12th week', 'description': "This parent-reported questionnaire is a comprehensive assessment tool for identifying behavioral and emotional problems in children. It includes 100 items (scored 0-3) covering multiple domains such as anxiety, depression, social issues, and aggressive behavior, providing a detailed profile of the child's psychological functioning. The score ranges from 0-200, with a higher score representing higher concern of behavior problems."}, {'measure': 'Changes of Sleep and Appetite', 'timeFrame': 'Baseline, 8th week and 12th week', 'description': 'Use Fitbit and sleep diary to monitor the bedtime resistance, sleep resistance, sleep disordered breathing, night-waking, daytime sleepiness and sleep onset delay. Diet diary and InBody to monitor the change of appetite and body weight.'}], 'secondaryOutcomes': [{'measure': 'Parenting Stress Index, Fourth Edition Short Form , PSI-4-SF', 'timeFrame': 'Baseline and 8th week', 'description': 'The PSI-4-SF yields scores on the following subscales: 1) Parental Distress, 2) Parent-Child Dysfunctional Interaction, and 3) Difficult Child. The instrument has 36 items which are responded to on a 5-point scale ranging from Strongly Agree to Strongly Disagree. A Total Stress Score is obtained by combining the subscales. The software to score the PSI-4-SF provides a percentile score. Percentile scores between 16 and 84% are considered normal stress, while scores of 85-89% indicate high stress and scores of 90% or higher indicate stress levels that may be clinically significant.'}, {'measure': 'Visual Analogue Scale for Gastrointestinal Symptoms, VAS-GI', 'timeFrame': 'Baseline and 8th week', 'description': 'Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being.'}, {'measure': 'Clinical Global Impressions-Severity, CGI-S and Clinical Global Impressions-Improvement, CGI-I', 'timeFrame': 'Baseline, 8th week and 12th week', 'description': "Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of the patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients)."}, {'measure': 'The Patient Global Impression of Change (PGI-C)', 'timeFrame': '8th week and 12th week', 'description': 'The Patient Global Impression of Change (PGI-C) consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome. We exploratorily investigate participants\' subjective impression after intervention by PGI-C. The percentage of participant\'s response in each category, such as "very much improved", "minimally improved", "no change", or "minimally worse" were used to draw an overall conclusion of the intervention potential in the open-arm trial.'}, {'measure': 'Conners Continuous Performance Test 3rd Edition, Conners CPT 3', 'timeFrame': 'Baseline and 8th week', 'description': "Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used."}, {'measure': 'Oxidative stress', 'timeFrame': 'Baseline and 8th week', 'description': 'Oxidative stress, an imbalance between free radicals and antioxidants, is strongly linked to ADHD, contributing to cellular damage, neuroinflammation, and neurotransmitter issues, with studies showing lower antioxidant levels and higher stress markers in individuals with ADHD. Oxidative stress related biomarkers such as Salivary alpha-amylase, sAA, Catalase , CAT, Total antioxidant capacity , TAC, Melatonin, Cortisol will be tested.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADD', 'ADHD', 'food supplements'], 'conditions': ['ADHD - Attention Deficit Disorder With Hyperactivity', 'ADD/ADHD']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate whether postbiotics supplementation can improve ADHD symptoms, such as mood and sleep, in children. Furthermore, salivary biochemical profiles will be analyzed and dietary habits will be recorded to further explore the effects and mechanisms of action of postbiotics.\n\nResearch process: 80 subjects who meet the admission conditions will be recruited within three years after IRB approval. They will take the research capsules (postbiotics) in an open label design study and complete the 8-week intervention plus 4 weeks follow up trial period.', 'detailedDescription': "In recent years, increasing attention has been directed toward the impact of lifestyle and dietary factors on cognitive function, mood, and sleep. Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer health benefits to the host by modulating gut microbiota composition, intestinal barrier function, inflammatory responses, and antioxidant activity. Through these mechanisms, probiotics may contribute to host health by delaying disease progression, regulating pathological processes, and preventing disease-related complications. A growing body of basic and clinical evidence has further demonstrated associations between the gut microbiota, probiotic interventions, and a range of neuropsychiatric and neurodegenerative conditions, including stress-related disorders, autism spectrum disorder (ASD), anxiety, depression, and Parkinson's disease (PD).\n\nIn addition to live probiotics, increasing interest has been directed toward postbiotics, which are defined as preparations of inanimate microorganisms and/or their components that confer health benefits to the host. Postbiotics contain a variety of bioactive constituents, including cell wall components (such as peptidoglycans and lipoteichoic acids), intracellular contents, and microbial metabolites produced during fermentation. These components are known to interact with host immune and metabolic pathways, contributing to immunomodulatory, anti-inflammatory, antioxidant, and gut barrier-enhancing effects. Importantly, postbiotics may exert biological activities similar to those of live probiotics while avoiding several limitations associated with viable microorganisms.\n\nThe strain investigated in the present study is heat-treated Lactiplantibacillus plantarum. Although heat treatment abolishes its capacity for replication, the resulting postbiotic retains multiple bioactive components, including intact cell wall structures and postbiotic metabolites. Heat treatment also enhances product stability and shelf life, reduces sensitivity to environmental conditions, and ensures consistent dosing, thereby improving suitability for clinical application. From a safety perspective, postbiotics eliminate the risk of microbial translocation, infection, or horizontal gene transfer, which may be of particular concern in vulnerable populations such as children, the elderly, or individuals with compromised immune function. Consequently, postbiotics are increasingly regarded as a safe and reliable alternative to live probiotics in clinical research and practice.\n\nHeat-treated Lactiplantibacillus plantarum has been investigated in several clinical contexts, including ASD, attention-deficit/hyperactivity disorder (ADHD), and Parkinson's disease, demonstrating potential benefits in modulating neurological and behavioral outcomes. Collectively, these findings support the rationale for further investigation of postbiotic interventions as a stable, safe, and biologically active strategy for targeting gut-brain axis-related conditions"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 6-13 years old\n2. Has been diagnosed with ADHD and is taking medication regularly or has not yet started medication.\n\nExclusion Criteria:\n\n1. Have taken antibiotics within one month or are receiving antibiotic treatment\n2. Have used probiotic products in powder, capsule or tablet form within one month (including yogurt, yogurt, Yakult and other related foods)\n3. Those who are allergic to lactic acid bacteria products\n4. Obtain a disability certificate\n5. Participating in other human research\n6. Determined unsuitable by the investigator'}, 'identificationModule': {'nctId': 'NCT07419659', 'briefTitle': 'Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'CMUH114-REC3-212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postbiotics', 'description': 'Dietary Supplement', 'interventionNames': ['Dietary Supplement: postbiotics']}], 'interventions': [{'name': 'postbiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants will consume 2 capsules of postbiotics supplement per day for 8 weeks', 'armGroupLabels': ['Postbiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404332', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I-Ching Chou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bened Biomedical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'I-Ching Chou', 'investigatorAffiliation': 'China Medical University Hospital'}}}}