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Peanut Protein for Peanut Allergy (CAFETERIA Trial)
CAFETERIA Trial Summary
This trial is testing whether kids with a high threshold for peanut allergies can eat small amounts of peanuts to build up a tolerance, and if this changes their quality of life.
CAFETERIA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CAFETERIA Trial Design
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Who is running the clinical trial?
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- You have participated in any studies or trials for treating food allergies within the last year.You have taken experimental drugs within the past year.You have received treatments like anti-IgE or other biologic medications within the past year.You have certain types of digestive disorders or inflammation in the esophagus or stomach.You are currently undergoing treatment to help reduce your allergies.You have taken certain antihistamines within a week before a specific test called DBPCFC or skin testing.You are currently taking certain types of medications for blood pressure or heart conditions, like beta-blockers or ACE inhibitors.You have a long-term illness that requires ongoing treatment, except for asthma, atopic dermatitis, or rhinitis.You have taken multiple rounds of oral steroids in the last year.You have taken certain types of allergy medication, like diphenhydramine, within the last three days before the allergy test.
- Group 1: Treatment
- Group 2: Avoidance
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Will geriatric participants be included in this investigation?
"As indicated by the inclusionary criteria, this trial is open to those between 4 and 14 years old. Additionally, there are 88 studies for minors under 18 and 158 study opportunities available for people above 65."
Has the recruitment phase for this trial commenced?
"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, initially posted on August 5th 2019, is enrolling patients. 74 participants must be recruited from 1 of the available sites."
To whom is participation in this clinical trial being offered?
"This study is seeking 74 children aged 4 to 14 with a confirmed peanut allergy. To be eligible, the patient (or their guardian) must provide informed consent and have IgE levels of 0.35 kUA/L or higher after avoiding peanuts for at least three days before screening. Furthermore, patients should be able to consume between 143 mg and 5043 mg of peanut protein during oral food challenge testing on the day of screening. Informed consent from both parent(s)/guardian(s) and child are necessary in order to participate in this trial."
Does this medication have governmental sanctioning?
"Adequate prior evidence confirms that this therapeutic intervention is safe, and thus it has been awarded a score of 2 on the Power scale. However, since this is still a Phase 2 trial, data supporting efficacy remains absent."
What is the upper limit of participants in this experiment?
"That is correct. Clinicaltrials.gov shows that the trial, initially posted on August 5th 2019, is still seeking participants with 74 patients to be recruited from 1 location."
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