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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
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Oscar Garcia Algar, Parc de Salut Mar

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.


Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome (FAS) Dietary Supplement: Epigallocatechin gallate Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in values of cognitive and neuropsychologic diagnostic scales of FAS [ Time Frame: 18 months (0, 4, 6, 12 and 18 months) ]

Secondary Outcome Measures :
  1. Change of values of oxidative stress biomarkers [ Time Frame: 18 months (0, 6, 12 and 18 months) ]


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Refuse of parents to participate
  2. Unfulfillment of inclusion criteria
  3. Any condition in children preventing from FAS diagnostics tests application

Information from the National Library of Medicine

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


Locations
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Spain
Parc de Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Fundación Mutua Madrileña
Investigators
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Principal Investigator: Oscar Garcia-Algar, PhD Parc de Salut Mar

Publications:
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Responsible Party: Oscar Garcia Algar, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02558933     History of Changes
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
Keywords provided by Oscar Garcia Algar, Parc de Salut Mar:
Fetal Alcohol Syndrome
Prenatal exposure
Biomarkers
Oxidative stress
Epigallocatechin gallate
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Syndrome
Disease
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Epigallocatechin gallate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents