Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-20 @ 3:42 PM
Study NCT ID:
NCT06258135
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072242', 'term': "4'-galactooligosaccharide"}, {'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parental anxiety: covariate of child outcome.', 'timeFrame': 'Baseline, End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Self report instrument: state-trait anxiety inventory (STAI) - Trait scale.'}, {'measure': 'Parental emotion processing: covariate of child outcome.', 'timeFrame': 'Baseline, End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Performance on behavioural task: emotional dot-probe task.'}, {'measure': 'Parent depression', 'timeFrame': 'Baseline, End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Self report instrument: Becks depression inventory (BDI-II).'}, {'measure': 'Parent attention networks', 'timeFrame': 'Baseline, End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Performance on behavioural task: attention network test.'}], 'primaryOutcomes': [{'measure': 'Changes in trait anxiety.', 'timeFrame': 'End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.'}, {'measure': 'Changes in emotion processing.', 'timeFrame': 'End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Performance on behavioural task: emotional dot-probe task.'}], 'secondaryOutcomes': [{'measure': 'Changes in depression.', 'timeFrame': 'End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Self report instrument: child depression inventory (CDI).'}, {'measure': 'Changes in attention networks.', 'timeFrame': 'End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Performance on behavioural task: attention network test (ANT) adapted for use by children.'}, {'measure': 'Changes in nutrient intake', 'timeFrame': 'End of treatment (4 weeks), Follow up (8 weeks).', 'description': 'Self report instrument: food diary completed over 4 days, average intakes calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emotional Regulation']}, 'referencesModule': {'references': [{'pmid': '40025494', 'type': 'DERIVED', 'citation': 'Johnstone N, Cohen Kadosh K. Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent. Nutr J. 2025 Mar 1;24(1):34. doi: 10.1186/s12937-025-01098-5.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Typically developing, healthy male or female aged 6-14 years\n* Access to home laptop/ personal computer\n\nExclusion Criteria:\n\n* Current clinical levels of anxiety and/or co-morbid psychological diagnoses\n* Neuro/developmental disorders\n* Gastro-intestinal problems or disease\n* Restrictive diets (e.g., lactose intolerance, gluten free)'}, 'identificationModule': {'nctId': 'NCT06258135', 'briefTitle': 'At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).', 'orgStudyIdInfo': {'id': 'FearlessStudy4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'interventionNames': ['Dietary Supplement: Galacto-oligosaccharide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Galacto-oligosaccharide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single 7g dose daily for 28 days', 'armGroupLabels': ['Treatment']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single 7g dose daily for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XH', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'University of Surrey', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'collaborators': [{'name': 'FrieslandCampina', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}