Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT00850668
Eligibility Criteria:
Inclusion Criteria:
* Available for the duration of the trial
* Ability to perform spirometry maneuvers
* Agree to use effective methods of contraception for the duration of the study
* For Step 1 participants, regular consumption of at least 5 grams of peanut at least twice per month during the last 6 months prior to study entry
* For Step 2 participants, a convincing clinical history of peanut allergy and prick skin test positive to peanut. More information on these criteria can be found in the protocol.
Exclusion Criteria:
* History of any severe anaphylaxis
* Known allergy to hydroxypropyl methylcellulose, glycerol, or phenol
* Evidence of clinically significant immunosuppressive neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Laboratory evidence of liver or hematologic disease. Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
* Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
* Any previous intubation due to allergies or asthma
* History of ischemic cardiovascular disease
* Uncontrolled hypertension
* Significant medical condition that, in the opinion of the investigator, would interfere with the study
* Chronic diarrhea
* Inability to refrain from anal intercourse for the duration of the trial
* Use of rectal medications during the study
* Planned rectal procedures for the duration of the study
* History of rectal surgery or bleeding in the last 6 months prior to study entry
* History of proctitis in the last 6 months prior to study entry
* History of inflammatory bowel disease, celiac disease, or eosinophilic esophagitis/gastroenteritis
* Participation in another investigational vaccine or drug trial within 30 days prior to study or while the study is ongoing
* Medical, occupational, or family problems as a result of alcohol or illicit drug use during the last 12 months prior to study entry
* FEV1 value less than 80% predicted
* Inability to discontinue antihistamines for skin testing
* Currently on any allergy immunotherapy
* Participation in any interventional study for the treatment of food allergy in the past 12 months prior to study entry
* Poor control of persistent activation of atopic dermatitis
* Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory therapy or biologic therapy within the past 12 months prior to study entry
* Use of oral B-blockers, angiotensin-receptor blockers, or calcium channel blockers
* Use of immunosuppressive drugs within 30 days prior to study entry or while study is ongoing
* Use of corticosteroids within 30 days prior to study entry
* Use of steroid medications. More information on this criterion can be found in the protocol.
* History of serologic evidence of infection with HIV-1, HBV, or HCV
* Receipt of blood products within the past 6 months prior to study entry
* Inability to refrain from anal intercourse for the duration of the study
* Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, would interfere with the study
* Pregnant or breastfeeding
Step 1 participants:
* History of any allergy to food, including peanut
* Serum peanut-specific IgE greater than .35 kUa/L at screening
* Prick skin test (PST) to peanut more than 3mm in diameter at screening
* History of asthma
Step 2 participants:
* More than mild persistent asthma as defined in the protocol.
* Treatment for asthma, including: any hospitalization in the past year for asthma or any emergency room visit in the past 6 months for asthma.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00850668
Study Brief:
Protocol Section:
NCT00850668