Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children

NCT02558933 | Completed

• 1 other identifier: 2014/5553
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.

Conditions

Fetal Alcohol Syndrome (FAS)

Keywords

Fetal Alcohol Syndrome; Prenatal exposure; Biomarkers; Oxidative stress; Epigallocatechin gallate

Outcome Measures

Primary Outcomes (1)

• Change in values of cognitive and neuropsychologic diagnostic scales of FAS

  12 months (0, 6, and 12 months)

Secondary Outcomes (1)

• Change of values of oxidative stress biomarkers

  6 months (0 and 6 months)

Study Arms (1)

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

Dietary Supplement: Epigallocatechin gallate

Interventions

Epigallocatechin gallate DIETARY_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.

Epigallocatechin gallate (EGCG) treated

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• FAS diagnosed children between 7 and 14 y.o.
• Included in a previous cohort (ALMAR)
• Informed consent by parents

You may not qualify if:

• Refuse of parents to participate
• Any condition in children preventing from FAS diagnostics tests application

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• Parc de Salut Mar: collaborator

Study Sites (1)

Parc de Salut Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (5)

• 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.

  PMID: 26351940 BACKGROUND

• Vall 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.

  PMID: 25903753 BACKGROUND

• Joya 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.

  PMID: 25131946 BACKGROUND

• Garcia-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.

  PMID: 23164116 BACKGROUND

• Ramos-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. doi: 10.1038/s41598-025-34576-1. Online ahead of print.

  PMID: 41484421 DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Oscar Garcia-Algar, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 24, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 23, 2025

Record last verified: 2019-08

Locations

ES (1)