Fetal Alcohol Syndrome (FAS) Clinical Trial
Official title:
Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
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.
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
1. Cognitive and neuropsychologic diagnostic scales of FAS
2. Determination of values of oxidative stress
3. Determination of control biomarkers of the treatment
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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