Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Study Purpose

The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 4 to 17 (inclusive) - A convincing clinical history of peanut allergy.

- Immune markers consistent with peanut allergy.

- Serum IgE to peanut of >0.35 kUA/L and a skin prick test to peanut >8mm greater than the negative saline control -or- - Serum IgE to peanut of >5 kUA/L and a mean peanut wheal diameter on skin prick test 3 to 8mm greater than the negative saline control -or- - Serum IgE to peanut of >14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control.

- Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC) - Written informed consent from parent/guardian.

- Written assent from subjects above the age of 7.

Exclusion Criteria:

- • History of a chronic disease (other than asthma, allergic rhinitis, and atopic dermatitis) that is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen.

- History of mast cell disease.

- History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis.

- Any history or presence of autoimmune, cardiovascular disease, chronic lung disease (other than asthma), malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease, eosinophilic esophagitis or other eosinophilic gastrointestinal disease.

- Current participation in any other interventional study.

- Subject who has undergone any type of oral immunotherapy.

- Severe asthma or uncontrolled mild to moderate asthma.

- Uncontrolled atopic dermatitis.

- Current use of oral steroid medications.

- Use of >1 bursts of oral steroid medications in the past year.

- Inability to eat by mouth the fiber supplementation or placebo control and peanut flour for any reason.

- Use of any therapeutic antibody (biologic medication) or any immunomodulatory medication in the past 12 month (other than a short course of oral steroids) - Current use of any type of immunotherapy.

- Pregnancy or lactation.

- Allergy to potato or corn oat or cow's milk.

- Unwillingness to carry an epinephrine auto-injector.

- Unwillingness to comply with activity restrictions during OIT or any other study procedure

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05138757
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Chicago
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Christina E Ciaccio, MD
Principal Investigator Affiliation	University of Chicago
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Additional Details

By doing this study, we hope to learn if using a dietary fiber called a "prebiotic" helps increase the number of children who can tolerate eating 1043mg of peanut protein (or about 3-4 peanuts) after going through oral immunotherapy (OIT) to peanut. We are also trying to determine if this fiber will reduce the side effects of OIT and if so, we would like to find out if the reason it is working is by changing the bacteria in the gut. Participation in this research will last about five years.

Arms & Interventions

Arms

Experimental: Treatment Group

Subjects who meet inclusion criteria will be randomized 1:1. The treatment group will receive prebiotic therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the prebiotic. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus prebiotic therapy for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop prebiotic therapy and continue on maintenance POIT in extended observation for approximately 4 years.

Placebo Comparator: Control Group

Subjects who meet inclusion criteria will be randomized 1:1. The control group will receive placebo therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the placebo. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus placebo for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop placebo and continue on maintenance POIT in extended observation for approximately 4 years.

Interventions

Drug: - Prebiotic

A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.

Drug: - Placebo

A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Comer Children's Hospital, Chicago, Illinois

Status

Recruiting

Address

Comer Children's Hospital

Chicago, Illinois, 60637

Site Contact

Christina E Ciaccio, MD

[email protected]

773-834-4010

Hyde Park, Illinois

Status

Not yet recruiting

Address

University of Chicago- Department of Pediatrics

Hyde Park, Illinois, 60637

Site Contact

Toni A Ramirez, BS

[email protected]

773-702-1220 #44343

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