Dysbiosis in food allergy and implications for microbial therapeutics.
M Cecilia Berin
https://pubmed.ncbi.nlm.nih.gov/33463542Actively Recruiting
Phase 1
Phase 2
Age: 12Years - 55Years
All Genders
ID03936998
VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
Led by Massachusetts General Hospital · Updated on 2023-10-18
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
V
Vedanta Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational medicine VE416 combined with vancomycin and peanut oral immunotherapy (PNOIT) for people with persistent peanut allergy. This randomized, double-blind trial has four groups comparing VE416 given before or during PNOIT to low-dose PNOIT alone, aiming to see if VE416 may help reduce allergic reactions and is safe to use. The study includes four arms: one with vancomycin then VE416 before starting PNOIT; another with vancomycin and VE416 taken together with PNOIT; a third with placebo vancomycin and active VE416 with PNOIT; and a fourth with placebo vancomycin and placebo VE416 alongside active PNOIT. Treatments involve capsules taken daily for specified periods, with vancomycin given for 5 days and VE416 for 6 weeks in different sequences depending on the group. Participants aged 12 to 55 with a diagnosed peanut allergy will be involved over several phases lasting up to 54 weeks. They will undergo evaluations including allergy testing, monitoring for allergic reactions, and safety assessments. The main outcomes measured include the response after 7 and 23 weeks and longer-term efficacy and safety through 54 weeks. The study includes a maintenance phase and a blinded food challenge to assess tolerance.
CONDITIONS
Brief Title
VE416 for Treatment of Food Allergy
Who Can Participate
Age: 12Years - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- People aged 12 to 55 years with a documented history of peanut allergy
- Positive skin prick test to peanut or serum peanut-specific IgE of at least 5 kU/L at screening
- Ara h 2 specific IgE greater than 0.35 kU/L at screening
- Willingness to sign informed consent or have parent/legal guardian consent if appropriate
- Willingness to sign assent form if age appropriate
- For Phase II continuation, allergic reaction requiring treatment at 100 mg dose of peanut protein during Entry Challenge
You will not qualify if you...
- History of severe anaphylaxis with hypoxia, low blood pressure, neurological issues, or incontinence
- Severe or moderate asthma as defined by NHLBI guidelines
- Poorly controlled asthma with FEV1 less than 80%, frequent nighttime awakenings, or frequent rescue medication use
- Other severe or complicating medical problems including autoimmune or chronic inflammatory conditions and gastrointestinal inflammatory diseases
- Inability to perform or cooperate with oral food challenge procedures
- Inability to swallow size 0 capsule
- Primary immune deficiency
- Allergy to oat confirmed by testing and history
- Current use of beta blockers, ACE inhibitors, or MAO inhibitors
- Pregnant, planning pregnancy, or breastfeeding women of childbearing potential
- Low hematocrit or weight below 23 kg
- Use of systemic immunomodulatory treatments or biologics in past 6 months
- Any medical problems that may pose additional risks or interfere with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 17 weeks total: 5 days of vancomycin, 6 weeks of VE416, followed by peanut oral immunotherapy
Participants receive vancomycin and VE416 capsules along with peanut oral immunotherapy in varying sequences depending on their assigned group.
Weekly visits for up to 17 weeks
Follow-up
Duration - Up to 37 weeks after treatment
Participants are monitored for safety and efficacy after completing treatment with VE416 and peanut oral immunotherapy.
Regular follow-up visits up to 54 weeks
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
W
Wayne G Shreffler, MD, PhD
J
Jannat Gill, BDS, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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