Peanut Allergy
Conditions
Keywords
oral immunotherapy, fiber, Peanut, anaphylaxis, allergy, pediatrics, prebiotic, food allergy, microbiome, probiotic
Brief summary
The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.
Detailed description
By doing this study, we hope to learn if using a dietary fiber called a "prebiotic" helps increase the number of children who can tolerate eating 1043mg of peanut protein (or about 3-4 peanuts) after going through oral immunotherapy (OIT) to peanut. We are also trying to determine if this fiber will reduce the side effects of OIT and if so, we would like to find out if the reason it is working is by changing the bacteria in the gut. Participation in this research will last about five years.
Interventions
DRUGPrebiotic
A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.
DRUGPlacebo
A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 4 to 17 (inclusive) * A convincing clinical history of peanut allergy * Immune markers consistent with peanut allergy * Serum IgE to peanut of \>0.35 kUA/L and a skin prick test to peanut \>8mm greater than the negative saline control -or- * Serum IgE to peanut of \>5 kUA/L and a mean peanut wheal diameter on skin prick test 3 to 8mm greater than the negative saline control -or- * Serum IgE to peanut of \>14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control * Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC) * Written informed consent from parent/guardian * Written assent from subjects above the age of 7
Exclusion criteria
* • History of a chronic disease (other than asthma, allergic rhinitis, and atopic dermatitis) that is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen * History of mast cell disease * History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis * Any history or presence of autoimmune, cardiovascular disease, chronic lung disease (other than asthma), malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease, eosinophilic esophagitis or other eosinophilic gastrointestinal disease * Current participation in any other interventional study * Subject who has undergone any type of oral immunotherapy * Severe asthma or uncontrolled mild to moderate asthma * Uncontrolled atopic dermatitis * Current use of oral steroid medications * Use of \>1 bursts of oral steroid medications in the past year * Inability to eat by mouth the fiber supplementation or placebo control and peanut flour for any reason * Use of any therapeutic antibody (biologic medication) or any immunomodulatory medication in the past 12 month (other than a short course of oral steroids) * Current use of any type of immunotherapy * Pregnancy or lactation * Allergy to potato or corn oat or cow's milk * Unwillingness to carry an epinephrine auto-injector * Unwillingness to comply with activity restrictions during OIT or any other study procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC | At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment). | To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy | From first study intervention through the final exit food challenge visit, up to 15 months. | • To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy. |
| The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy | From first study intervention through the final exit food challenge visit, up to 15 months. | • To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina E Ciaccio, MD
University of Chicago
Participant flow
Recruitment details
Subjects were screened and enrolled at the University of Chicago.
Pre-assignment details
Twenty-two participants provided informed consent. Prior to assignment, two participants were determined to be ineligible because they did not demonstrate a reaction to peanut during the double-blind, placebo-controlled oral food challenge. The remaining 20 participants were enrolled and assigned.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 10-12 years | 4 Participants |
| Age, Customized Age 13-15 years | 3 Participants |
| Age, Customized Age 16-17 years | 2 Participants |
| Age, Customized Age 4-6 years | 1 Participants |
| Age, Customized Age 7-9 years | 2 Participants |
| Peanut skin prick test wheal size | 15.95 mm STANDARD_DEVIATION 8.78 |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race More than one race | 2 Participants |
| Race/Ethnicity, Customized Race White | 7 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 6 / 9 | 8 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
None listed