Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02558933
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063647', 'term': 'Fetal Alcohol Spectrum Disorders'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in values of cognitive and neuropsychologic diagnostic scales of FAS', 'timeFrame': '12 months (0, 6, and 12 months)'}], 'secondaryOutcomes': [{'measure': 'Change of values of oxidative stress biomarkers', 'timeFrame': '6 months (0 and 6 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fetal Alcohol Syndrome', 'Prenatal exposure', 'Biomarkers', 'Oxidative stress', 'Epigallocatechin gallate'], 'conditions': ['Fetal Alcohol Syndrome (FAS)']}, 'referencesModule': {'references': [{'pmid': '26351940', 'type': 'BACKGROUND', 'citation': 'Joya X, Marchei E, Salat-Batlle J, Garcia-Algar O, Calvaresi V, Pacifici R, Pichini S. Fetal exposure to ethanol: relationship between ethyl glucuronide in maternal hair during pregnancy and ethyl glucuronide in neonatal meconium. Clin Chem Lab Med. 2016 Mar;54(3):427-35. doi: 10.1515/cclm-2015-0516.'}, {'pmid': '25903753', 'type': 'BACKGROUND', 'citation': 'Vall O, Salat-Batlle J, Garcia-Algar O. Alcohol consumption during pregnancy and adverse neurodevelopmental outcomes. J Epidemiol Community Health. 2015 Oct;69(10):927-9. doi: 10.1136/jech-2014-203938. Epub 2015 Apr 22. No abstract available.'}, {'pmid': '25131946', 'type': 'BACKGROUND', 'citation': 'Joya X, Garcia-Algar O, Salat-Batlle J, Pujades C, Vall O. Advances in the development of novel antioxidant therapies as an approach for fetal alcohol syndrome prevention. Birth Defects Res A Clin Mol Teratol. 2015 Mar;103(3):163-77. doi: 10.1002/bdra.23290. Epub 2014 Aug 18.'}, {'pmid': '23164116', 'type': 'BACKGROUND', 'citation': 'Garcia-Algar O, Black D, Guerri C, Pichini S. The effect of different alcohol drinking patterns in early to mid-pregnancy. BJOG. 2012 Dec;119(13):1670-1. doi: 10.1111/1471-0528.12007. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.\n\nThe objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.\n\nPre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.", 'detailedDescription': "Background\n\n1% of children present a prenatal alcohol exposure related disorder. Prevalence of consumption increases every year. In a previous study in Barcelona, 45.5% of ethanol positive meconiums were detected, as a biomarker of maternal consumption of alcohol during pregnancy. The most serious clinical picture including facial, mental and cognitive disorders is Foetal Alcohol Syndrome (FAS). Spain is the second country in adoptions from East Europe, where the consumption of alcohol during pregnancy is most important. The only prevention of FAS is avoiding consumption of alcohol during pregnancy and there is no treatment for its deleterious effects on neurodevelopment.\n\nThe flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.\n\nObjective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.\n\nMethodology Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 5 and 16 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.\n\nInstrumentalization\n\n1. Cognitive and neuropsychologic diagnostic scales of FAS\n2. Determination of values of oxidative stress\n3. Determination of control biomarkers of the treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. FAS diagnosed children between 7 and 14 y.o.\n2. Included in a previous cohort (ALMAR)\n3. Informed consent by parents\n\nExclusion Criteria:\n\n1. Refuse of parents to participate\n2. Unfulfillment of inclusion criteria\n3. Any condition in children preventing from FAS diagnostics tests application'}, 'identificationModule': {'nctId': 'NCT02558933', 'acronym': 'Neuro-SAF', 'briefTitle': 'Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children', 'orgStudyIdInfo': {'id': '2014/5553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epigallocatechin gallate (EGCG) treated', 'description': 'Intervention: Epigallocatechin gallate (EGCG) administered FAS children: An oral dose of 9 mg/Kg/day of EGCG will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment', 'interventionNames': ['Dietary Supplement: Epigallocatechin gallate']}], 'interventions': [{'name': 'Epigallocatechin gallate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of Epigallocatechin gallate (EGCG). It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.', 'armGroupLabels': ['Epigallocatechin gallate (EGCG) treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Oscar Garcia-Algar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parc de Salut Mar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parc de Salut Mar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Óscar García-Algar', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}