An observational study in Peanut Allergy, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Massachusetts General Hospital · Observational
This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.
In this research study the investigators want to learn more about the experience of participants with peanut allergy and their caregivers undergoing food oral immunotherapy (OIT) for peanut allergy. Food oral immunotherapy (OIT) is a treatment for individuals with a food allergy to reduce the body's allergic response to the food allergen, resulting in fewer symptoms. The treatment is also called desensitization. An individual becomes desensitized to the food allergen by ingesting small amounts of the food that are slowly increased. Over time, this helps the body's immune system become used to the food so that it no longer causes an allergic reaction. By desensitizing to peanut, it may lower the risk of life-threatening allergic reactions and cause a decreased sensitivity to peanut. The investigators specifically want to learn more about the effects of food OIT on quality of life and other outcomes important to participants with peanut allergy and their caregivers and to ultimately develop tests to predict who may respond favorably to food OIT.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 500 is above the median of 220 across 30 observational studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric and adult individuals with food allergy as specified in the eligibility criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
active peanut oral immunotherapy
Drug: Peanut oral immunotherapy
Peanut oral immunotherapy for peanut allergy
Also known as: Peanut flour, Peanut allergen powder
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT
Feasibility analysis as assessed by the proportion of participants who tolerate the maintenance dose in a dichotomous manner
Time frame: 2 years
Change in quality of life scores from baseline to end of treatment
Change in quality of life scores from baseline assessment to end of treatment assessment using the Food Allergy Quality of Life Questionnaire (FAQLQ) total score. The FAQLQ total and domain scores range from 1-7 where 1 was the best possible score (i.e. fewest problems or better health related quality of life) and with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, and Food Anxiety.
Time frame: 4 years
Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment
Change in peanut specific serum immunoglobulin E (IgE) \[in kilo-units per liter (kU/L) or international units per milliliter (IU/mL)\] from baseline to end of treatment
Time frame: 4 years
Change in skin prick test reactivity to peanut extract from baseline to end of treatment
Change in skin prick test wheal diameter measurement in millimeters to peanut extract from baseline to end of treatment
Time frame: 4 years
The proportion of participants who tolerate a cumulative dose of 5000 mg peanut protein on oral food challenge without treatment after 12 months on maintenance dose
Desensitization to peanut as assessed by cumulative tolerated dose
Time frame: 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety analysis as assessed by patient-reported or observed allergic symptoms that will be analyzed and tabulated
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Dec 2026, 78 months after the start.
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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