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
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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 |
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 biomarkers of the treatment
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
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 |

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

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

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
Spain | |
Parc de Salut Mar | |
Barcelona, Spain, 08003 |
Principal Investigator: | Oscar Garcia-Algar, PhD | Parc de Salut Mar |
Responsible Party: | Oscar Garcia Algar, PhD, Parc de Salut Mar |
ClinicalTrials.gov Identifier: | NCT02558933 |
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 |
Fetal Alcohol Syndrome Prenatal exposure Biomarkers Oxidative stress Epigallocatechin gallate |
Fetal Alcohol Spectrum Disorders Syndrome Disease Pathologic Processes Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |
Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Neuroprotective Agents |