Food AllergyPI23/00820NCT06558526
Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients
A study testing Apple pectin (DE 57%) 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
Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. 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?
- Apple pectin (DE 57%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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) and with or without clinical history of food allergy with peanut.
- Sensitization to Pru p 3 by positive skin prick test (SPT wheal area >7 mm2) and specific IgE (sIgE >0.35 kUA/L)
- Positive DBPCFC with peach juice.
- If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE >0.35 kUA/L to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.
- Signed informed consent.
Who cannot join
- Food allergy to corn.
- Food allergy to peanut due to sensitization to storage proteins.
- Previous/active treatment with sublingual immunotherapy to Pru p 3.
- Pregnancy/lactation.
- Active infections.
- Inflammatory, autoimmune, and/or oncological diseases.
Show all 17Show fewer
- Severe immunodeficiency.
- Metabolic syndrome.
- Increased liver parameters and/or any liver disease.
- Alcohol disorder.
- Mental illness.
- Mast cell activation syndrome.
- Severe atopic dermatitis.
- FEV1 < 70%
- Treatment with immunomodulators in the last five years.
- Vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.
- Any clinical condition contraindicating performance of DBPCFC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29009
Natalia Pérez, Dr., +34951290224, nataliai.perez.sspa@juntadeandalucia.es
About this study
Official title: Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up
Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.
Read the detailed description
Patients of 3 different Allergy Units with clinical history of allergic reactions with peach and with/without reactions with peanut due to sensitization to nsLTP will be informed about the intervention study and potential risks. After obtention of written informed consent, screening phase evaluation will be performed (skin prick tests (SPT), obtention of blood and feces samples and double-blind placebo-controlled food challenges (DBPCFC) with peach and peanut). Participants who meet the eligibility requirements will be randomized in a ratio 1:1 to pectin (apple pectin 10 mg + maltodextrin 5 mg; once daily) or placebo (maltodextrin 5 mg; once daily). The dietary intervention will last 6 months and a follow-up visit in month 3 will be performed. After completing the dietary intervention all participants will be clinically assessed (SPT and DBPCFC) and new blood and feces samples will be collected. Finally, patients who receive the active will be clinically evaluated with DBPCFC to peach and peanut after 6 months of completing the dietary intervention. Also, new blood and feces samples will be obtained.
The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study. In addition, the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect (immunological humoral and cellular, metabolomics and microbiota profiles). Furthermore, long-term effects of the dietary intervention will be analyzed in participants from the active group (pectin) 6 months after completing the intervention.
- Conditions
- Food Allergy
- Being tested
- Apple pectin (DE 57%), Placebo
- Keywords
- nsLTP allergy, Dietary intervention, Pectin, Microbiome, Immunomodulation, Food allergy treatment
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple pectin (DE 57%)Dietary supplement
Also called Herbapekt
Dietary intervention with apple pectin. Participants will orally take the supplement once a day, after dissolving it in 100 ml of water, for 6 months.
PlaceboDietary supplement
Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pectin intervention group | Experimental | This group will orally take 10 g of apple pectin (DE 57%) + 5 g of maltodextrin once a day during 6 months. Receives: Dietary Supplement: Apple pectin (DE 57%) |
| Placebo group | Placebo comparator | This group will orally take 5 g of maltodextrin once a day during 6 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 a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP.
Clinical efficacy will be defined as an increase in oral tolerance to peach and/or peanut determined through the DBPCFCs performed pre- and post- dietary intervention, compared to the Placebo.
Measured: 15 months
Secondary outcomes (13)
Correlation between the induced changes in oral tolerance to peach and/or peanut and the reactivity in skin prick test (SPT).
Changes in oral tolerance to peach and/or peanut (see Primary outcome). Reactivity in SPT to Pru p 3 and peanut will be defined by the size of the papule area (mm2) measured pre- and post- dietary intervention.
Measured: 15 months
Changes in Pru p 3 and Ara h 9 (nsLTP of peach and peanut, respectively) specific immunoglobulin production (IgE and IgG4) induced by the pectin dietary intervention.
Results will be expresses as kUA/L.
Measured: 15 months
Changes in Pru p 3 and Ara h 9-specific basophil activation induced by the pectin dietary intervention
Results will be presented as the percentage of activated basophils (CD63+CD203c+CCR3+) and basophil allergen threshold sensitivity (CD-Sens).
Measured: 15 months
Maturational changes in Pru p 3 and Ara h 9-specific dendritics cells induced by the pectin dietary intervention.
Results will be expressed as maturation index (MI).
Measured: 15 months
Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary 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: 15 months
Changes on gastrointestinal microbiota induced by the pectin dietary intervention.
Analysis of bacteria composition: relative abundance (%) and alpha-, beta diversity as Jensen Shannon divergence (JSD) (PChao1 vs PChao2).
Measured: 15 months
Changes on feces metabolome induced by the pectin dietary intervention.
Metabolomic profile from feces samples will be analyzed 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: 15 months
Changes on serum metabolome induced by the pectin dietary intervention.
Metabolomic profile from serum samples will be analyzed 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: 15 months
Pectin dietary intervention long-term clinical efficacy.
Peach and peanut oral tolerance after 6 months of completing the dietary intervention with the active (pectin) will be determine through DBPCFCs.
Measured: 12 months
Pectin dietary intervention long-term effect on the immunological profile.
Determination and analysis of Pru p 3 and Ara h 9-specific IgE and IgG4 production, basophil activation, dendritic cell maturation and proliferative response of different lymphocytes cell subpopulations, after 6 months of completing the dietary intervention with the active (pectin). Each determination will be performed and measured as same as for the related previous outcomes mentioned.
Measured: 12 months
Pectin dietary intervention long-term effect on the gastrointestinal microbiota.
Analysis of gastrointestinal microbiota composition after 6 months of completing the dietary intervention with the active (pectin). Relative abundance (%) and alpha-, beta diversity as Jensen Shannon divergence (JSD) (PChao1 vs PChao2).
Measured: 12 months
Pectin dietary intervention long-term effect on feces metabolome.
Analysis by a combination of mass spectrometry techniques after 6 months of completing the dietary intervention with the active (pectin). Results will be expressed as μg/g.
Measured: 12 months
Pectin dietary intervention long-term effect on serum metabolome.
Analysis by a combination of mass spectrometry techniques after 6 months of completing the dietary intervention with the active (pectin). Results will be expressed as μg/mL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start13 Jan 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 62 participants (estimated)
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
- Natalia Pérez Sánchez, MD, PhD, Principal investigator, Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558526
- Sponsor's protocol ID
- PI23/00820
- Acronym
- PI23/00820
- Status last verified
- Jun 2025
- First submitted
- 14 Aug 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The present study will adhere to FAIR (Findable, Accessible, Interoperable, and Reusable data) data principles. 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
Fernandez-Rivas M, Gonzalez-Mancebo E, Rodriguez-Perez R, Benito C, Sanchez-Monge R, Salcedo G, Alonso MD, Rosado A, Tejedor MA, Vila C, Casas ML. Clinically relevant peach allergy is related to peach lipid transfer protein, Pru p 3, in the Spanish population. J Allergy Clin Immunol. 2003 Oct;112(4):789-95. doi: 10.1016/S0091.
PubMed 14564363Skypala IJ, Asero R, Barber D, Cecchi L, Diaz Perales A, Hoffmann-Sommergruber K, Pastorello EA, Swoboda I, Bartra J, Ebo DG, Faber MA, Fernandez-Rivas M, Gomez F, Konstantinopoulos AP, Luengo O, van Ree R, Scala E, Till SJ; European Academy of Allergy; Clinical Immunology (EAACI) Task Force: Non-specific Lipid Transfer Protein Allergy Across Europe. Non-specific lipid-transfer proteins: Allergen structure and function, cross-reactivity, sensitization, and epidemiology. Clin Transl Allergy. 2021 May 18;11(3):e12010. doi: 10.1002/clt2.12010. eCollection 2021 May.
PubMed 34025983Noval Rivas M, Burton OT, Wise P, Zhang YQ, Hobson SA, Garcia Lloret M, Chehoud C, Kuczynski J, DeSantis T, Warrington J, Hyde ER, Petrosino JF, Gerber GK, Bry L, Oettgen HC, Mazmanian SK, Chatila TA. A microbiota signature associated with experimental food allergy promotes allergic sensitization and anaphylaxis. J Allergy Clin Immunol. 2013 Jan;131(1):201-12. doi: 10.1016/j.jaci.2012.10.026. Epub 2012 Nov 30.
PubMed 23201093Bunyavanich S, Berin MC. Food allergy and the microbiome: Current understandings and future directions. J Allergy Clin Immunol. 2019 Dec;144(6):1468-1477. doi: 10.1016/j.jaci.2019.10.019.
PubMed 31812181Zhu Z, Zhu B, Hu C, Liu Y, Wang X, Zhang J, Wang F, Zhu M. Short-chain fatty acids as a target for prevention against food allergy by regulatory T cells. JGH Open. 2019 Jan 8;3(3):190-195. doi: 10.1002/jgh3.12130. eCollection 2019 Jun.
PubMed 31276034Tan 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 27332875Steigerwald H, Blanco-Perez F, Albrecht M, Bender C, Wangorsch A, Endress HU, Bunzel M, Mayorga C, Torres MJ, Scheurer S, Vieths S. Does the Food Ingredient Pectin Provide a Risk for Patients Allergic to Non-Specific Lipid-Transfer Proteins? Foods. 2021 Dec 21;11(1):13. doi: 10.3390/foods11010013.
PubMed 35010137
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up
- ClinicalTrials.gov ID
- NCT06558526
- Acronym / sponsor ID
- PI23/00820 / PI23/00820
- Conditions
- Food Allergy
- Keywords
- nsLTP allergy, Dietary intervention, Pectin, Microbiome, Immunomodulation, Food allergy treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Aug 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.
Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.
Detailed description
Patients of 3 different Allergy Units with clinical history of allergic reactions with peach and with/without reactions with peanut due to sensitization to nsLTP will be informed about the intervention study and potential risks. After obtention of written informed consent, screening phase evaluation will be performed (skin prick tests (SPT), obtention of blood and feces samples and double-blind placebo-controlled food challenges (DBPCFC) with peach and peanut). Participants who meet the eligibility requirements will be randomized in a ratio 1:1 to pectin (apple pectin 10 mg + maltodextrin 5 mg; once daily) or placebo (maltodextrin 5 mg; once daily). The dietary intervention will last 6 months and a follow-up visit in month 3 will be performed. After completing the dietary intervention all participants will be clinically assessed (SPT and DBPCFC) and new blood and feces samples will be collected. Finally, patients who receive the active will be clinically evaluated with DBPCFC to peach and peanut after 6 months of completing the dietary intervention. Also, new blood and feces samples will be obtained.
The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study. In addition, the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect (immunological humoral and cellular, metabolomics and microbiota profiles). Furthermore, long-term effects of the dietary intervention will be analyzed in participants from the active group (pectin) 6 months after completing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectin intervention group | Experimental | Dietary Supplement: Apple pectin (DE 57%)This group will orally take 10 g of apple pectin (DE 57%) + 5 g of maltodextrin once a day during 6 months. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group will orally take 5 g of maltodextrin once a day during 6 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and/or systemic symptoms) and with or without clinical history of food allergy with peanut.
- Sensitization to Pru p 3 by positive skin prick test (SPT wheal area >7 mm2) and specific IgE (sIgE >0.35 kUA/L)
- Positive DBPCFC with peach juice.
- If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE >0.35 kUA/L to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.
- Signed informed consent.
Key exclusion criteria (17 listed)
- Food allergy to corn.
- Food allergy to peanut due to sensitization to storage proteins.
- Previous/active treatment with sublingual immunotherapy to Pru p 3.
- Pregnancy/lactation.
- Active infections.
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 |
|---|---|---|
| Apple pectin (DE 57%)Also: HerbapektDietary intervention with apple pectin. Participants will orally take the supplement once a day, after dissolving it in 100 ml of water, for 6 months. | Dietary supplement | Pectin intervention group |
| PlaceboDietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months. | Dietary supplement | Placebo group |
Primary outcome
Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP.
Time frame: 15 months
Clinical efficacy will be defined as an increase in oral tolerance to peach and/or peanut determined through the DBPCFCs performed pre- and post- dietary intervention, compared to the Placebo.
13 secondary outcomes
Correlation between the induced changes in oral tolerance to peach and/or peanut and the reactivity in skin prick test (SPT).
Time frame: 15 months
Changes in Pru p 3 and Ara h 9 (nsLTP of peach and peanut, respectively) specific immunoglobulin production (IgE and IgG4) induced by the pectin dietary intervention.
Time frame: 15 months
Changes in Pru p 3 and Ara h 9-specific basophil activation induced by the pectin dietary intervention
Time frame: 15 months
Maturational changes in Pru p 3 and Ara h 9-specific dendritics cells induced by the pectin dietary intervention.
Time frame: 15 months
Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary intervention.
Time frame: 15 months
Changes on gastrointestinal microbiota induced by the pectin dietary intervention.
Time frame: 15 months
Changes on feces metabolome induced by the pectin dietary intervention.
Time frame: 15 months
Changes on serum metabolome induced by the pectin dietary intervention.
Time frame: 15 months
Pectin dietary intervention long-term clinical efficacy.
Time frame: 12 months
Pectin dietary intervention long-term effect on the immunological profile.
Time frame: 12 months
Pectin dietary intervention long-term effect on the gastrointestinal microbiota.
Time frame: 12 months
Pectin dietary intervention long-term effect on feces metabolome.
Time frame: 12 months
Pectin dietary intervention long-term effect on serum metabolome.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 14564363Fernandez-Rivas M, Gonzalez-Mancebo E, Rodriguez-Perez R, Benito C, Sanchez-Monge R, Salcedo G, Alonso MD, Rosado A, Tejedor MA, Vila C, Casas ML. Clinically relevant peach allergy is related to peach lipid transfer protein, Pru p 3, in the Spanish population. J Allergy Clin Immunol. 2003 Oct;112(4):789-95. doi: 10.1016/S0091.
- Results publication: PubMed 34025983Skypala IJ, Asero R, Barber D, Cecchi L, Diaz Perales A, Hoffmann-Sommergruber K, Pastorello EA, Swoboda I, Bartra J, Ebo DG, Faber MA, Fernandez-Rivas M, Gomez F, Konstantinopoulos AP, Luengo O, van Ree R, Scala E, Till SJ; European Academy of Allergy; Clinical Immunology (EAACI) Task Force: Non-specific Lipid Transfer Protein Allergy Across Europe. Non-specific lipid-transfer proteins: Allergen structure and function, cross-reactivity, sensitization, and epidemiology. Clin Transl Allergy. 2021 May 18;11(3):e12010. doi: 10.1002/clt2.12010. eCollection 2021 May.
- Results publication: PubMed 23201093Noval Rivas M, Burton OT, Wise P, Zhang YQ, Hobson SA, Garcia Lloret M, Chehoud C, Kuczynski J, DeSantis T, Warrington J, Hyde ER, Petrosino JF, Gerber GK, Bry L, Oettgen HC, Mazmanian SK, Chatila TA. A microbiota signature associated with experimental food allergy promotes allergic sensitization and anaphylaxis. J Allergy Clin Immunol. 2013 Jan;131(1):201-12. doi: 10.1016/j.jaci.2012.10.026. Epub 2012 Nov 30.
- Results publication: PubMed 31812181Bunyavanich S, Berin MC. Food allergy and the microbiome: Current understandings and future directions. J Allergy Clin Immunol. 2019 Dec;144(6):1468-1477. doi: 10.1016/j.jaci.2019.10.019.
- Results publication: PubMed 31276034Zhu Z, Zhu B, Hu C, Liu Y, Wang X, Zhang J, Wang F, Zhu M. Short-chain fatty acids as a target for prevention against food allergy by regulatory T cells. JGH Open. 2019 Jan 8;3(3):190-195. doi: 10.1002/jgh3.12130. eCollection 2019 Jun.
- Results publication: 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.
- Results publication: PubMed 35010137Steigerwald H, Blanco-Perez F, Albrecht M, Bender C, Wangorsch A, Endress HU, Bunzel M, Mayorga C, Torres MJ, Scheurer S, Vieths S. Does the Food Ingredient Pectin Provide a Risk for Patients Allergic to Non-Specific Lipid-Transfer Proteins? Foods. 2021 Dec 21;11(1):13. doi: 10.3390/foods11010013.
- Individual participant dataSharing planned: Yes. The present study will adhere to FAIR (Findable, Accessible, Interoperable, and Reusable data) data principles. 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.
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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.
Natalia Pérez Sánchez, 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 Apple pectin (DE 57%) 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 15 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Pérez Sánchez, MD, PhD (+34 951290224, nataliai.perez.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP. (time frame: 15 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 NCT06558526, which also lists 7 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 15 Jun 2025.