Is NCT05695261 recruiting in Boston, MA?

Yes, NCT05695261 is currently recruiting participants at its Boston, MA location. This allergy, peanut clinical trial is actively enrolling qualified participants.

How do I join the allergy, peanut clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Allergy, Peanut Clinical Trial in Boston, MA

About This Allergy, Peanut Study in Boston

This is a phase II trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective for Part A is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \<=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.

Sponsor: Rima Rachid

Who Can Participate

Inclusion Criteria

Male and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.

Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines at 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only).

Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).

For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted

Has a negative urine hCG test if a female participant.

Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and sexually active. An example of a single-barrier method of contraception includes condoms or oral contraceptives. Acceptable methods of birth control include implants, injectables, combined oral contraceptives, some intrauterine contraceptive devises (IUDs), sexual abstinence, a vasectomized partner, the contraceptive patch, the contraceptive ring, and condoms.

Able to swallow 2 empty capsules size 00.

Able to give informed assent and guardian willing to give informed consent.

Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection

Willing to undergo telephone or email follow-up to assess for safety and adverse events.

Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).

Exclusion Criteria

Subjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.

Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)

For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome, and excluding other foods that the MTT donor avoided)

For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk estimated to be above the LOAEL in 4 capsules, and excluding oral allergy syndrome, excluding the food that the patient is undergoing immunotherapy to, and excluding other foods that the MTT donor avoided).

Patients with chronic illness other than controlled asthma that is mild intermittent, mild- persistent or moderate persistent, mild eczema and allergic rhinitis. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.

Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.

Patients on chronic systemic immunosuppressive therapies.

Patients who are diagnosed with active, chronic urticaria.

Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).

Patients who are on the up-dosing phase of aeroallergen immunotherapy or patients who have received Omalizumab or dupilumab therapy within the past 6 months.

Women who are pregnant or breast feeding or planning to get pregnant during the time of the study.

Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit

Patient with GI conditions including inflammatory bowel disease, eosinophilic esophagitis, food protein induced enterocolitis, uncontrolled reflux despite medication, uncontrolled chronic constipation despite medication, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening.

Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.

Patients with neutropenia \<1000 cells/uL

Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion.

Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.

Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05695261) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Allergy, Peanut Treatment Options in Boston, MA

If you're searching for allergy, peanut treatment options in Boston, MA, this clinical trial (NCT05695261) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced allergy, peanut specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all allergy, peanut clinical trials near you to find additional studies recruiting in your area.

Allergy, Peanut Clinical Trial in Boston, MA

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