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.
- Peanut Allergy
2 Primary · 2 Secondary · Reporting Duration: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC
4 Treatment Groups
Placebo plus placebo with PNOIT
1 of 4
Placebo plus VE416 with PNOIT
1 of 4
vancomycin plus VE416 before PNOIT
1 of 4
Vancomycin plus VE416 with PNOIT
1 of 4
60 Total Participants · 4 Treatment Groups
Primary Treatment: Vancomycin plus VE416 with PNOIT · Has Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 12 - 55 · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Berin, M. Cecilia. 2021. “Dysbiosis in Food Allergy and Implications for Microbial Therapeutics”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci144994.
- Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.
- Wayne G. Shreffler, MD, PhD 2019. "VE416 for Treatment of Food Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03936998.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor