NCT06558526 Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients
| NCT ID | NCT06558526 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-01-13 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Natalia Pérez Sánchez, MD, PhD
PRINCIPAL INVESTIGATOR
Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
Frequently Asked Questions
Who can join the NCT06558526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06558526 currently recruiting?
Yes, NCT06558526 is actively recruiting participants. Contact the research team at nataliai.perez.sspa@juntadeandalucia.es for enrollment information.
Where is the NCT06558526 trial being conducted?
This trial is being conducted at Málaga, Spain.
Who is sponsoring the NCT06558526 clinical trial?
NCT06558526 is sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. The principal investigator is Natalia Pérez Sánchez, MD, PhD at Allergy Clinical Unit, Hospital Regional Universitario de Málaga, Málaga, Spain. The trial plans to enroll 62 participants.