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VE416 for Peanut Allergy
Study Summary
This trial is testing VE416 as a possible treatment for peanut allergies. It is comparing it to low-dose peanut oral immunotherapy (PNOIT) to see if it is more effective.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are unable to swallow a small-sized pill.You have a weakened immune system from birth.You have used other treatments that affect your immune system within the past 6 months, including allergy shots or certain medications that target the immune system.People of any race, gender, or ethnicity between the ages of 12 and 55 who have a medical record showing they are allergic to peanuts.You have experienced a severe allergic reaction in the past that caused difficulty breathing, low blood pressure, confusion, or loss of consciousness.You have other serious medical conditions like autoimmune diseases or chronic inflammation in your immune system or digestive system.You had an allergic reaction that needed treatment when you were given 100 mg of peanut protein during the initial test.You have severe or moderate asthma, which means your asthma symptoms are more serious and require careful management.You are unable to follow instructions or participate in the process of trying different foods orally.
- Group 1: Vancomycin plus VE416 with PNOIT
- Group 2: Placebo plus VE416 with PNOIT
- Group 3: vancomycin plus VE416 before PNOIT
- Group 4: Placebo plus placebo with PNOIT
- 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
What pathological conditions are customarily treated with Vancomycin plus VE416 in conjunction with PNOIT?
"By combining Vancomycin with VE416 and PNOIT, one can successfully treat staphylococcal contagions, infections caused by staph bacteria, as well as enterocolitis induced by Staphylococcus aureus."
Are there particular demographics that would be optimal for this experiment?
"This study is looking for 60 participants aged 12 to 55 years old with a documented history of peanut allergies. In order to qualify, those interested must be from all backgrounds and genders, have had an allergic reaction requiring treatment after ingesting 100 mgs of peanut protein during the entry challenge, and consent if they are age-appropriate."
What is the aggregate size of the cohort participating in this clinical trial?
"Affirmative, the information present on clinicaltrials.gov attests to this trial's active recruitment of participants. It was originally posted June 28th 2019 and recently revised April 4th 2022, with 60 people needed at one research centre."
Is enrollment still available for this research endeavor?
"Affirmative, the data hosted on clinicaltrials.gov attests to this study's recruitment status; it was posted in June 28th 2019 and last updated April 4th 2022. The trial is seeking 60 subjects at a single site."
Can you provide details on any prior experiments involving the combination of Vancomycin plus VE416 with PNOIT?
"Presently, there are 55 active clinical trials utilizing Vancomycin plus VE416 with PNOIT. Of these studies, 6 have progressed to Stage 3 of the trial process. While most of them are located in Jupiter, Florida, they span 315 sites globally."
Is this experiment in need of volunteers who are at least twenty years old?
"Those seeking to participate in this medical trial must fall between 12 and 55 years of age. Additionally, there are 94 separate studies available for minors, while those older than 65 can access 201 different clinical trials."
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