Clinical Trial: Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
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.
Detailed Summary:
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
- Cognitive and neuropsychologic diagnostic scales of FAS
- Determination of values of oxidative stress
- Determination of control biomar
Sponsor: Parc de Salut Mar
Current Primary Outcome: Change in values of cognitive and neuropsychologic diagnostic scales of FAS [ Time Frame: 18 months (0, 4, 6, 12 and 18 months) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change of values of oxidative stress biomarkers [ Time Frame: 18 months (0, 6, 12 and 18 months) ]
Original Secondary Outcome: Same as current
Information By: Parc de Salut Mar
Dates:
Date Received: September 22, 2015
Date Started: June 2015
Date Completion: April 2017
Last Updated: September 23, 2015
Last Verified: September 2015
