Fetal Alcohol Syndrome (FAS)Neuro-SAFNCT02558933
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
A study testing Epigallocatechin gallate in people with Fetal Alcohol Syndrome (FAS), run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Fetal Alcohol Syndrome (FAS)
- What is being tested?
- Epigallocatechin gallate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- FAS diagnosed children between 7 and 14 y.o.
- Included in a previous cohort (ALMAR)
- Informed consent by parents
Who cannot join
- Refuse of parents to participate
- Unfulfillment of inclusion criteria
- Any condition in children preventing from FAS diagnostics tests application
Trial locations and contacts
1 site in 1 country.
About this study
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 three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Read the 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 5 and 16 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Instrumentalization
- Cognitive and neuropsychologic diagnostic scales of FAS
- Determination of values of oxidative stress
- Determination of control biomarkers of the treatment
- Conditions
- Fetal Alcohol Syndrome (FAS)
- Being tested
- Epigallocatechin gallate
- Keywords
- Fetal Alcohol Syndrome, Prenatal exposure, Biomarkers, Oxidative stress, Epigallocatechin gallate
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin gallateDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Epigallocatechin gallate (EGCG) treated | Experimental | 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 Receives: Dietary Supplement: Epigallocatechin gallate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in values of cognitive and neuropsychologic diagnostic scales of FAS
Measured: 12 months (0, 6, and 12 months)
Secondary outcomes (1)
Change of values of oxidative stress biomarkers
Measured: 6 months (0 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Syndrome (FAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Parc de Salut Mar
- Responsible party
- Principal investigator, Óscar García-Algar, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Oscar Garcia-Algar, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558933
- Sponsor's protocol ID
- 2014/5553
- Acronym
- Neuro-SAF
- Status last verified
- Aug 2019
- First submitted
- 22 Sep 2015
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Joya X, Marchei E, Salat-Batlle J, Garcia-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.
PubMed 26351940Vall 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. No abstract available.
PubMed 25903753Joya 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.
PubMed 25131946Garcia-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. No abstract available.
PubMed 23164116Ramos-Triguero A, Astals-Vizcaino M, Navarro-Tapia E, Vieiros M, Bastons-Compta A, Martinez L, Andreu-Fernandez V, Garcia-Algar O. Cognitive and transcriptomic effects of Epigallocatechin gallate in fetal alcohol spectrum disorders. Sci Rep. 2026 Jan 2;16(1):4461. doi: 10.1038/s41598-025-34576-1.
PubMed 41484421
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
- ClinicalTrials.gov ID
- NCT02558933
- Acronym / sponsor ID
- Neuro-SAF / 2014/5553
- Conditions
- Fetal Alcohol Syndrome (FAS)
- Keywords
- Fetal Alcohol Syndrome, Prenatal exposure, Biomarkers, Oxidative stress, Epigallocatechin gallate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Parc de Salut Mar
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
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 5 and 16 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Instrumentalization
- Cognitive and neuropsychologic diagnostic scales of FAS
- Determination of values of oxidative stress
- Determination of control biomarkers of the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epigallocatechin gallate (EGCG) treated | Experimental | Dietary Supplement: Epigallocatechin gallateIntervention: 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 |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- FAS diagnosed children between 7 and 14 y.o.
- Included in a previous cohort (ALMAR)
- Informed consent by parents
Key exclusion criteria (3 listed)
- Refuse of parents to participate
- Unfulfillment of inclusion criteria
- Any condition in children preventing from FAS diagnostics tests application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigallocatechin gallatePre 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. | Dietary supplement | Epigallocatechin gallate (EGCG) treated |
Primary outcome
Change in values of cognitive and neuropsychologic diagnostic scales of FAS
Time frame: 12 months (0, 6, and 12 months)
1 secondary outcome
Change of values of oxidative stress biomarkers
Time frame: 6 months (0 and 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 26351940Joya X, Marchei E, Salat-Batlle J, Garcia-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.
- Background: PubMed 25903753Vall 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. No abstract available.
- Background: PubMed 25131946Joya 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.
- Background: PubMed 23164116Garcia-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. No abstract available.
- Derived from this study: PubMed 41484421Ramos-Triguero A, Astals-Vizcaino M, Navarro-Tapia E, Vieiros M, Bastons-Compta A, Martinez L, Andreu-Fernandez V, Garcia-Algar O. Cognitive and transcriptomic effects of Epigallocatechin gallate in fetal alcohol spectrum disorders. Sci Rep. 2026 Jan 2;16(1):4461. doi: 10.1038/s41598-025-34576-1.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Garcia-Algar, PhD principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigallocatechin gallate in people with Fetal Alcohol Syndrome (FAS), run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in values of cognitive and neuropsychologic diagnostic scales of FAS (time frame: 12 months (0, 6, and 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558933, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.