Food AllergyAC18/00031NCT06386081
Dietary Intervention in Food Allergy
A study testing Citrus pectin with low DE and Apple pectin with high DE in people with Food Allergy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Citrus pectin with low DE and Apple pectin with high DE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 30 Jun 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and/or systemic symptoms)
- Sensitization to Pru p 3 by positive skin prick test (SPT wheal area >7 mm2) and specific IgE (sIgE >0.35 kU/L)
- Positive DBPCFC (Sampson 2012) with peach juice
- Signed informed consent
Who cannot join
- Any clinical condition contraindicating performance of DBPCFC
- A negative result in the DBPCFC
- Lactation
- Active infections
- Acute/chronic inflammatory, autoimmune, and/or oncological diseases
- Diabetes
Show all 15Show fewer
- Obesity
- Severe immunodeficiency
- Metabolic syndrome
- Alcohol disorder
- Mental illness
- Increased liver parameters and any liver disease
- Smoking habit
- Enzymatic deficiency
- Being vegetarian and taking vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months, and immunomodulators and/or immunotherapy in the last five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intervention in Food Allergy: Microbiome, Epigenetic and Metabolomic Interactions
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.
Read the 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, e.g. 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.
- Conditions
- Food Allergy
- Being tested
- Citrus pectin with low DE, Apple pectin with high DE, Placebo
- Keywords
- Pectin, Dietary intervention, nsLTP allergy, Immunoregulation, Microbiome
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus pectin with low DEDietary supplement
Also called Classic pectin
Dietary intervention with citrus pectin with low DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months.
Apple pectin with high DEDietary supplement
Also called Herbapekt
Dietary intervention with apple pectin with high DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months.
PlaceboDietary supplement
Participants will orally take the placebo (maltodextrin) twice a day, after dissolving it in 100ml of water, for 2 months. Maltodextrin is highly digestible and in small amounts will have limited impact on gut microbiome.
| Study group | Role | What they receive |
|---|---|---|
| Citrus pectin dietary intervention group | Experimental | This group will orally take 10 g of citrus pectin with low DE (7,3%) + 5 g of maltodextrin twice a day during two months. Receives: Dietary Supplement: Citrus pectin with low DE |
| Apple pectin intervention group | Experimental | This group will orally take 10 g of apple pectin with high DE (57%) + 5 g of maltodextrin twice a day during two months. Receives: Dietary Supplement: Apple pectin with high DE |
| Placebo group | Placebo comparator | This group will orally take placebo (5 g of maltodextrin) twice a day during two months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of pectin dietary intervention in nsLTP allergic patients
Clinical efficacy is defined as a significant increase in Pru p 3 (μg) tolerance, measured through DBPCFC performed before and after the pectin intervention, compared to the Placebo.
Measured: 16 months
Secondary outcomes (9)
Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention
Results will be expressed as kUA/L.
Measured: 18 months
Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention
Results will be expressed as maturation index (MI).
Measured: 18 months
Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention
The specific proliferation responses of different lymphocytes subpopulations will be measured: Th1, Th2, Th9, and Plasma-cells/IgE+, T regulatory cells (Treg), Treg/IL10+ and B regulatory cells/ IL10+. The results will be expressed as fold change of proliferation index (PI).
Measured: 18 months
Changes in Pru p 3-specific basophil activation induced by pectin intervention
Results will be presented as the percentage of activated basophils (CD63+CD203c+CCR3+) and basophil allergen threshold sensitivity (CD-Sens).
Measured: 18 months
Changes induced in the taxonomic diversity of gut microbiota
STAMP (Statistical Analysis of Metagenomic Profiles, v2.1.3) will be used to identify particular taxa that significantly differ in abundance (%) between groups.
Measured: 18 months
Changes in feaces metabolome induced by pectin dietary intervention
Metabolomic profile from feaces samples will be analysed using a combination of untargeted mass spectrometry techniques: liquid chromatography-mass spectrometry (LC-ESI-QTOF-MS) and capillary electrophoresis-mass spectrometry (CE-TOF-MS). Results will be expressed as µg/g.
Measured: 18 months
Changes in serum metabolome induced by the pectin dietary intervention
Metabolomic profile from serum samples will be analysed by a combination of liquid chromatography-mass spectrometry (LC-MS) and gas chromatography coupled to mass spectrometry (GC-MS). Results will be expressed as µg/mL.
Measured: 18 months
Epigenomic changes induced by the pectin dietary intervention
Analysis of the methylome will be performed by EPIC array (Illumina).
Measured: 18 months
Pectin safety profile
Analysis of the frequency of adverse events induced by pectin supplement. Determination of liver function parameters, appearance of allergic reactions and/or gastrointestinal symptoms.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jan 2021
- Primary completion31 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María José Torres, MD, PhD, Principal investigator, Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386081
- Sponsor's protocol ID
- AC18/00031
- Acronym
- AC18/00031
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DIFAMEM study will adhere to FAIR data principles (Findable, Accessible, Interoperable, and Reusable data). We will make all data available as appropriate, including a detailed description of protocols and analysis pipelines, to ensure that results can be reproduced, and to facilitate further analysis and development of this work by other groups. We will make the data preserved accessible, and used in accordance with scientific norms of fair attribution and use.
Publications
Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.
PubMed 24390308Tan J, McKenzie C, Vuillermin PJ, Goverse G, Vinuesa CG, Mebius RE, Macia L, Mackay CR. Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect against Food Allergy through Diverse Cellular Pathways. Cell Rep. 2016 Jun 21;15(12):2809-24. doi: 10.1016/j.celrep.2016.05.047.
PubMed 27332875Krautkramer KA, Kreznar JH, Romano KA, Vivas EI, Barrett-Wilt GA, Rabaglia ME, Keller MP, Attie AD, Rey FE, Denu JM. Diet-Microbiota Interactions Mediate Global Epigenetic Programming in Multiple Host Tissues. Mol Cell. 2016 Dec 1;64(5):982-992. doi: 10.1016/j.molcel.2016.10.025. Epub 2016 Nov 23.
PubMed 27889451Villasenor A, Rosace D, Obeso D, Perez-Gordo M, Chivato T, Barbas C, Barber D, Escribese MM. Allergic asthma: an overview of metabolomic strategies leading to the identification of biomarkers in the field. Clin Exp Allergy. 2017 Apr;47(4):442-456. doi: 10.1111/cea.12902.
PubMed 28160515Zhang Z, Shi L, Pang W, Liu W, Li J, Wang H, Shi G. Dietary Fiber Intake Regulates Intestinal Microflora and Inhibits Ovalbumin-Induced Allergic Airway Inflammation in a Mouse Model. PLoS One. 2016 Feb 12;11(2):e0147778. doi: 10.1371/journal.pone.0147778. eCollection 2016.
PubMed 26872019Tian L, Bruggeman G, van den Berg M, Borewicz K, Scheurink AJ, Bruininx E, de Vos P, Smidt H, Schols HA, Gruppen H. Effects of pectin on fermentation characteristics, carbohydrate utilization, and microbial community composition in the gastrointestinal tract of weaning pigs. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600186. Epub 2016 Jun 20.
PubMed 27198846Savage J, Johns CB. Food allergy: epidemiology and natural history. Immunol Allergy Clin North Am. 2015 Feb;35(1):45-59. doi: 10.1016/j.iac.2014.09.004. Epub 2014 Nov 21.
PubMed 25459576Fernandez-Rivas M, Bolhaar S, Gonzalez-Mancebo E, Asero R, van Leeuwen A, Bohle B, Ma Y, Ebner C, Rigby N, Sancho AI, Miles S, Zuidmeer L, Knulst A, Breiteneder H, Mills C, Hoffmann-Sommergruber K, van Ree R. Apple allergy across Europe: how allergen sensitization profiles determine the clinical expression of allergies to plant foods. J Allergy Clin Immunol. 2006 Aug;118(2):481-8. doi: 10.1016/j.jaci.2006.05.012. Epub 2006 Jun 27.
PubMed 16890775Gomez F, Aranda A, Campo P, Diaz-Perales A, Blanca-Lopez N, Perkins J, Garrido M, Blanca M, Mayorga C, Torres MJ. High prevalence of lipid transfer protein sensitization in apple allergic patients with systemic symptoms. PLoS One. 2014 Sep 11;9(9):e107304. doi: 10.1371/journal.pone.0107304. eCollection 2014.
PubMed 25210741Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
PubMed 23195525
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention in Food Allergy: Microbiome, Epigenetic and Metabolomic Interactions
- ClinicalTrials.gov ID
- NCT06386081
- Acronym / sponsor ID
- AC18/00031 / AC18/00031
- Conditions
- Food Allergy
- Keywords
- Pectin, Dietary intervention, nsLTP allergy, Immunoregulation, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Apr 2024 (actual)
- 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 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.
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, e.g. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Citrus pectin dietary intervention group | Experimental | Dietary Supplement: Citrus pectin with low DEThis group will orally take 10 g of citrus pectin with low DE (7,3%) + 5 g of maltodextrin twice a day during two months. |
| Apple pectin intervention group | Experimental | Dietary Supplement: Apple pectin with high DEThis group will orally take 10 g of apple pectin with high DE (57%) + 5 g of maltodextrin twice a day during two months. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group will orally take placebo (5 g of maltodextrin) twice a day during two months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and/or systemic symptoms)
- Sensitization to Pru p 3 by positive skin prick test (SPT wheal area >7 mm2) and specific IgE (sIgE >0.35 kU/L)
- Positive DBPCFC (Sampson 2012) with peach juice
- Signed informed consent
Key exclusion criteria (15 listed)
- Any clinical condition contraindicating performance of DBPCFC
- A negative result in the DBPCFC
- Lactation
- Active infections
- Acute/chronic inflammatory, autoimmune, and/or oncological diseases
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 |
|---|---|---|
| Citrus pectin with low DEAlso: Classic pectinDietary intervention with citrus pectin with low DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months. | Dietary supplement | Citrus pectin dietary intervention group |
| Apple pectin with high DEAlso: HerbapektDietary intervention with apple pectin with high DE. Participants will orally take the supplement twice a day, after dissolving it in 100ml of water, for 2 months. | Dietary supplement | Apple pectin intervention group |
| PlaceboParticipants will orally take the placebo (maltodextrin) twice a day, after dissolving it in 100ml of water, for 2 months. Maltodextrin is highly digestible and in small amounts will have limited impact on gut microbiome. | Dietary supplement | Placebo group |
Primary outcome
Clinical efficacy of pectin dietary intervention in nsLTP allergic patients
Time frame: 16 months
Clinical efficacy is defined as a significant increase in Pru p 3 (μg) tolerance, measured through DBPCFC performed before and after the pectin intervention, compared to the Placebo.
9 secondary outcomes
Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention
Time frame: 18 months
Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention
Time frame: 18 months
Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention
Time frame: 18 months
Changes in Pru p 3-specific basophil activation induced by pectin intervention
Time frame: 18 months
Changes induced in the taxonomic diversity of gut microbiota
Time frame: 18 months
Changes in feaces metabolome induced by pectin dietary intervention
Time frame: 18 months
Changes in serum metabolome induced by the pectin dietary intervention
Time frame: 18 months
Epigenomic changes induced by the pectin dietary intervention
Time frame: 18 months
Pectin safety profile
Time frame: 16 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 26 Apr 2024.
- Background: PubMed 24390308Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.
- Background: PubMed 27332875Tan J, McKenzie C, Vuillermin PJ, Goverse G, Vinuesa CG, Mebius RE, Macia L, Mackay CR. Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect against Food Allergy through Diverse Cellular Pathways. Cell Rep. 2016 Jun 21;15(12):2809-24. doi: 10.1016/j.celrep.2016.05.047.
- Background: PubMed 27889451Krautkramer KA, Kreznar JH, Romano KA, Vivas EI, Barrett-Wilt GA, Rabaglia ME, Keller MP, Attie AD, Rey FE, Denu JM. Diet-Microbiota Interactions Mediate Global Epigenetic Programming in Multiple Host Tissues. Mol Cell. 2016 Dec 1;64(5):982-992. doi: 10.1016/j.molcel.2016.10.025. Epub 2016 Nov 23.
- Background: PubMed 28160515Villasenor A, Rosace D, Obeso D, Perez-Gordo M, Chivato T, Barbas C, Barber D, Escribese MM. Allergic asthma: an overview of metabolomic strategies leading to the identification of biomarkers in the field. Clin Exp Allergy. 2017 Apr;47(4):442-456. doi: 10.1111/cea.12902.
- Background: PubMed 26872019Zhang Z, Shi L, Pang W, Liu W, Li J, Wang H, Shi G. Dietary Fiber Intake Regulates Intestinal Microflora and Inhibits Ovalbumin-Induced Allergic Airway Inflammation in a Mouse Model. PLoS One. 2016 Feb 12;11(2):e0147778. doi: 10.1371/journal.pone.0147778. eCollection 2016.
- Background: PubMed 27198846Tian L, Bruggeman G, van den Berg M, Borewicz K, Scheurink AJ, Bruininx E, de Vos P, Smidt H, Schols HA, Gruppen H. Effects of pectin on fermentation characteristics, carbohydrate utilization, and microbial community composition in the gastrointestinal tract of weaning pigs. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600186. Epub 2016 Jun 20.
- Background: PubMed 25459576Savage J, Johns CB. Food allergy: epidemiology and natural history. Immunol Allergy Clin North Am. 2015 Feb;35(1):45-59. doi: 10.1016/j.iac.2014.09.004. Epub 2014 Nov 21.
- Background: PubMed 16890775Fernandez-Rivas M, Bolhaar S, Gonzalez-Mancebo E, Asero R, van Leeuwen A, Bohle B, Ma Y, Ebner C, Rigby N, Sancho AI, Miles S, Zuidmeer L, Knulst A, Breiteneder H, Mills C, Hoffmann-Sommergruber K, van Ree R. Apple allergy across Europe: how allergen sensitization profiles determine the clinical expression of allergies to plant foods. J Allergy Clin Immunol. 2006 Aug;118(2):481-8. doi: 10.1016/j.jaci.2006.05.012. Epub 2006 Jun 27.
- Background: PubMed 25210741Gomez F, Aranda A, Campo P, Diaz-Perales A, Blanca-Lopez N, Perkins J, Garrido M, Blanca M, Mayorga C, Torres MJ. High prevalence of lipid transfer protein sensitization in apple allergic patients with systemic symptoms. PLoS One. 2014 Sep 11;9(9):e107304. doi: 10.1371/journal.pone.0107304. eCollection 2014.
- Background: PubMed 23195525Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
- Individual participant dataSharing planned: Yes. DIFAMEM study will adhere to FAIR data principles (Findable, Accessible, Interoperable, and Reusable data). We will make all data available as appropriate, including a detailed description of protocols and analysis pipelines, to ensure that results can be reproduced, and to facilitate further analysis and development of this work by other groups. We will make the data preserved accessible, and used in accordance with scientific norms of fair attribution and use.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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.
María José Torres, MD, PhD principal investigator
Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus pectin with low DE and Apple pectin with high DE in people with Food Allergy, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 4 inclusion and 15 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 26 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Clinical efficacy of pectin dietary intervention in nsLTP allergic patients (time frame: 16 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 NCT06386081, which also lists 10 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 26 Apr 2024.