Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386081
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-04
Brief Title:
Dietary Intervention in Food Allergy
Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Organization:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study Overview
Official Title:
Dietary Intervention in Food Allergy Microbiome Epigenetic and Metabolomic Interactions
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AC1800031
Brief Summary:
The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins nsLTP allergic patients The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins
Participants will be enrolled to receive a two-month dietary intervention with either two different pectins citrus or apple pectin or placebo Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge DBPCFC Microbiome proteomic and metabolomic studies will also be performed in blood and stool samples
Participants will be enrolled to receive a two-month dietary intervention with either two different pectins citrus or apple pectin or placebo Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge DBPCFC Microbiome proteomic and metabolomic studies will also be performed in blood and stool samples
Detailed Description:
DIFAMEM is an original integrative project that aims to use the potential of a pectin-enriched diet to treat food allergy comprehensively addressing its effects on the epigenome and microbiome metabolomic modifications and immune modulation DIFAMEM has been approved by the Regulatory Authorities and Ethics Research Committee of Malaga
In recent years the microbiome has gained attention as a target of intervention against food allergy eg through the use of prebiotics which are non-digestible food components that stimulate the growth and activity of certain microorganisms There is currently great interest in the potential of plant-derived dietary fiber as a protective component against allergies based on promising results which have been obtained in asthma models Dietary fibers such as pectin can alter the gut microbiota and lead to increased local and systemic concentrations of gut microbiota-derived short chain fatty acids SCFAs SCFAs including acetate propionate and butyrate can promote the generation of peripheral regulatory T cells by epigenetic modulation and suppress the inflammatory function of dendritic cells DC by transcriptional modulation It is probable that additional metabolites also play an important role in these processes Therefore metabolomics applied in an untargeted approach for food allergy is an attractive option for the discovery of novel metabolites This technology has been used to show a relationship between the beneficial effects upon using prebiotics and changes in faecal metabolites
Pectin is a polysaccharide that occurs naturally in fruits mainly in the peel and core It has been recently reported that a diet supplemented with pectin alters the ratio of Firmicutes to Bacteroidetes in gut and lung microbiota increases the concentrations of SCFAs in faeces and sera and reduces the development of airway inflammation by suppressing DC function via engagement of GPR41 free fatty acid receptor 3 FFAR3 Notably natural apple pectin has been shown to have an immunomodulatory effect on allergies although the mechanisms still need to be elucidated The dominant component of pectin is a linear chain of galacturonic acid GalA in which a proportion of the carboxyl acid groups are present as methylesters The ratio of esterified GalA groups to total GalA groups is termed the degree of esterification DE Two types of pectin exist high methoxy pectin HMP with DE 50 or low methoxy pectin LMP with DE 50 The majority of natural pectin is HMP whereas LMP is more common in processed foods Both HMP and LMP appear to possess immunomodulatory effects and increase SCFA levels in treated mice LMP is more efficiently fermented by the microbiota in the ileum whereas HMP is mainly fermented in the proximal colon These data suggest that the different types of pectin may exert their immunomodulatory effects through different mechanisms however little is known about the different types of pectin in relation to food allergy
Food allergy has dramatically increased in prevalence by over 50 during the last decade and is estimated to affect 5 of adults and 8 of children Fruits are the most frequent triggers in adolescents and adults worldwide The Rosaceae family contains the most often involved fruits with non-specific lipid transfer proteins nsLTPs the primary sensitizers such as the major peach allergen Pru p 3 NsLTPs are panallergens associated with sensitization to multiple taxonomically unrelated plant-derived foods They are very stable and can cause a complex clinical pattern known as LTP-syndrome which includes life-threatening reactions such as anaphylaxis This syndrome even in milder forms can greatly impact quality of life and causes high socio-economic cost
The DIFAMEM study is based on the hypothesis that dietary intervention will lead to beneficial effects for food allergic patients using a natural food constituent with prebiotic properties like pectins Such an intervention would be safer than specific allergen immunotherapy avoiding allergic side effects Studying the mechanisms of this intervention by modern innovative omics technologies will allow us to further optimize the approach in a targeted fashion
Participants with a confirmed nsLTP allergy from the Allergy Unit of Hospital Regional Universitario de Málaga will be enrolled after informed consent obtention to receive a dietary intervention with two different pectins citrus low DE or apple high DE or placebo DBPCFC with known quantities of Pru p 3 will be performed before and after the dietary intervention to determine improvement in nsLTP oral tolerance Blood and stool samples will also be collected before and after the intervention to analyze the effects on the epigenome and microbiome metabolomic modifications and immune modulation
In recent years the microbiome has gained attention as a target of intervention against food allergy eg through the use of prebiotics which are non-digestible food components that stimulate the growth and activity of certain microorganisms There is currently great interest in the potential of plant-derived dietary fiber as a protective component against allergies based on promising results which have been obtained in asthma models Dietary fibers such as pectin can alter the gut microbiota and lead to increased local and systemic concentrations of gut microbiota-derived short chain fatty acids SCFAs SCFAs including acetate propionate and butyrate can promote the generation of peripheral regulatory T cells by epigenetic modulation and suppress the inflammatory function of dendritic cells DC by transcriptional modulation It is probable that additional metabolites also play an important role in these processes Therefore metabolomics applied in an untargeted approach for food allergy is an attractive option for the discovery of novel metabolites This technology has been used to show a relationship between the beneficial effects upon using prebiotics and changes in faecal metabolites
Pectin is a polysaccharide that occurs naturally in fruits mainly in the peel and core It has been recently reported that a diet supplemented with pectin alters the ratio of Firmicutes to Bacteroidetes in gut and lung microbiota increases the concentrations of SCFAs in faeces and sera and reduces the development of airway inflammation by suppressing DC function via engagement of GPR41 free fatty acid receptor 3 FFAR3 Notably natural apple pectin has been shown to have an immunomodulatory effect on allergies although the mechanisms still need to be elucidated The dominant component of pectin is a linear chain of galacturonic acid GalA in which a proportion of the carboxyl acid groups are present as methylesters The ratio of esterified GalA groups to total GalA groups is termed the degree of esterification DE Two types of pectin exist high methoxy pectin HMP with DE 50 or low methoxy pectin LMP with DE 50 The majority of natural pectin is HMP whereas LMP is more common in processed foods Both HMP and LMP appear to possess immunomodulatory effects and increase SCFA levels in treated mice LMP is more efficiently fermented by the microbiota in the ileum whereas HMP is mainly fermented in the proximal colon These data suggest that the different types of pectin may exert their immunomodulatory effects through different mechanisms however little is known about the different types of pectin in relation to food allergy
Food allergy has dramatically increased in prevalence by over 50 during the last decade and is estimated to affect 5 of adults and 8 of children Fruits are the most frequent triggers in adolescents and adults worldwide The Rosaceae family contains the most often involved fruits with non-specific lipid transfer proteins nsLTPs the primary sensitizers such as the major peach allergen Pru p 3 NsLTPs are panallergens associated with sensitization to multiple taxonomically unrelated plant-derived foods They are very stable and can cause a complex clinical pattern known as LTP-syndrome which includes life-threatening reactions such as anaphylaxis This syndrome even in milder forms can greatly impact quality of life and causes high socio-economic cost
The DIFAMEM study is based on the hypothesis that dietary intervention will lead to beneficial effects for food allergic patients using a natural food constituent with prebiotic properties like pectins Such an intervention would be safer than specific allergen immunotherapy avoiding allergic side effects Studying the mechanisms of this intervention by modern innovative omics technologies will allow us to further optimize the approach in a targeted fashion
Participants with a confirmed nsLTP allergy from the Allergy Unit of Hospital Regional Universitario de Málaga will be enrolled after informed consent obtention to receive a dietary intervention with two different pectins citrus low DE or apple high DE or placebo DBPCFC with known quantities of Pru p 3 will be performed before and after the dietary intervention to determine improvement in nsLTP oral tolerance Blood and stool samples will also be collected before and after the intervention to analyze the effects on the epigenome and microbiome metabolomic modifications and immune modulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None