Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Condition: Fetal Alcohol Syndrome (FAS)
MeSH terms: Fetal Alcohol Spectrum Disorders; Syndrome
Study type: Interventional

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.
    

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

        1. Cognitive and neuropsychologic diagnostic scales of FAS

        2. Determination of values of oxidative stress

        3. Determination of control biomarkers of the treatment
    

Intervention name(s): Epigallocatechin gallate
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention MeSH terms: Epigallocatechin gallate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fetal Alcohol Syndrome; Prenatal exposure; Biomarkers; Oxidative stress; Epigallocatechin gallate