Neuro-SAF: Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Study Details
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 |
|---|---|---|
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N/A |
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.
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.
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
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Cognitive and neuropsychologic diagnostic scales of FAS
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Determination of values of oxidative stress
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Determination of control biomarkers of the treatment
Study Design
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.
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Outcome Measures
Primary Outcome Measures
- Change in values of cognitive and neuropsychologic diagnostic scales of FAS [18 months (0, 4, 6, 12 and 18 months)]
Secondary Outcome Measures
- Change of values of oxidative stress biomarkers [18 months (0, 6, 12 and 18 months)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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FAS diagnosed children between 7 and 14 y.o.
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Included in a previous cohort (ALMAR)
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Informed consent by parents
Exclusion Criteria:
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Refuse of parents to participate
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Unfulfillment of inclusion criteria
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Any condition in children preventing from FAS diagnostics tests application
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parc de Salut Mar | Barcelona | Spain | 08003 |
Sponsors and Collaborators
- Parc de Salut Mar
- Fundación Mutua Madrileña
Investigators
- Principal Investigator: Oscar Garcia-Algar, PhD, Parc de Salut Mar
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 2014/5553