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NCT05165329
A Randomized, Controlled Trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Tolerance in Hong Kong Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
NA trial testing PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations in Peanut Allergy in 90 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 11 November 2021 |
| Primary completion | 30 September 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 4 locations across Hong Kong |
Drugs / interventions tested
- PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations
- PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations
- PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.
Conditions studied
- Peanut Allergy — all drugs for Peanut Allergy →
- Food Allergy in Children — all drugs for Food Allergy in Children →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 1 to 17, any sex, with Peanut Allergy or Food Allergy in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed. This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Feast for thought: A comprehensive review of food allergy 2021-2023.
Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918 -
Commensal collaborations: Food allergy and the microbiome.
Arditi Z, Bunyavanich S. · · 2023 · cited 10× · PMID 37558058 · DOI 10.1016/j.jaci.2023.08.001 -
Microbiome Therapeutics for Food Allergy.
Chernikova DA, Zhao MY, Jacobs JP. · · 2022 · cited 8× · PMID 36501184 · DOI 10.3390/nu14235155 -
Safety Profile of Probiotics as an Adjuvant to Oral Immunotherapy for Food Allergies: A Meta Analysis of Randomized Controlled Trials.
Hussein M, Essam S, Mekky ME, Ahmed L, et al · · 2026 · PMID 40320506 · DOI 10.1007/s12602-025-10544-z
Verify or expand the search:
- PubMed search for NCT05165329
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05165329 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 8 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05165329.
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