Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children (Neuro-SAF)

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ClinicalTrials.gov Identifier: NCT02558933

Recruitment Status : Completed

First Posted : September 24, 2015

Last Update Posted : August 30, 2019

Sponsor:

Collaborator:

Fundación Mutua Madrileña

Information provided by (Responsible Party):

Oscar Garcia Algar, Parc de Salut Mar

Study Description

Brief Summary:

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.

The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.

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 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.

Condition or disease	Intervention/treatment	Phase
Fetal Alcohol Syndrome (FAS)	Dietary Supplement: Epigallocatechin gallate	Not Applicable

Detailed Description:

Background

1% 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.

Objective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.

Methodology 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 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.

Instrumentalization

Cognitive and neuropsychologic diagnostic scales of FAS
Determination of values of oxidative stress
Determination of control biomarkers of the treatment

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Study Start Date :	March 2016
Actual Primary Completion Date :	October 2016
Actual Study Completion Date :	September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fetal Alcohol Spectrum Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Epigallocatechin gallate (EGCG) treated 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	Dietary Supplement: Epigallocatechin gallate 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.

Outcome Measures

Primary Outcome Measures :

Change in values of cognitive and neuropsychologic diagnostic scales of FAS [ Time Frame: 18 months (0, 4, 6, 12 and 18 months) ]

Secondary Outcome Measures :

Change of values of oxidative stress biomarkers [ Time Frame: 18 months (0, 6, 12 and 18 months) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

FAS diagnosed children between 7 and 14 y.o.
Included in a previous cohort (ALMAR)
Informed consent by parents

Exclusion Criteria:

Refuse of parents to participate
Unfulfillment of inclusion criteria
Any condition in children preventing from FAS diagnostics tests application

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558933

Locations

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Spain
Parc de Salut Mar
Barcelona, Spain, 08003

Sponsors and Collaborators

Parc de Salut Mar

Fundación Mutua Madrileña

Investigators

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Principal Investigator:	Oscar Garcia-Algar, PhD	Parc de Salut Mar

More Information

Publications:

Joya X, Marchei E, Salat-Batlle J, García-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.

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.

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. Review.

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.

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Responsible Party:	Oscar Garcia Algar, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier:	NCT02558933 History of Changes
Other Study ID Numbers:	2014/5553
First Posted:	September 24, 2015 Key Record Dates
Last Update Posted:	August 30, 2019
Last Verified:	August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Oscar Garcia Algar, Parc de Salut Mar:


Fetal Alcohol Syndrome Prenatal exposure Biomarkers Oxidative stress Epigallocatechin gallate

Additional relevant MeSH terms:

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Fetal Alcohol Spectrum Disorders Syndrome Disease Pathologic Processes Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Ethanol Epigallocatechin gallate	Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Neuroprotective Agents

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