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Completed

NCT Number: NCT05138757

Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

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.

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Key information

Conditions

Peanut Allergy Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Comer Children's Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC

    Time frame: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC.

Secondary outcomes

  1. The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy

    Time frame: From first study intervention through the final exit food challenge visit, up to 15 months.

    • To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy.

  2. The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy

    Time frame: From first study intervention through the final exit food challenge visit, up to 15 months.

    • To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy

Other outcomes

  1. Fecal Butyrate Concentration (mM)

    Time frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    Fecal samples were collected at each study time point and analyzed for butyrate concentration using metabolomic profiling. Results are reported in millimolar (mM).

  2. Change in Peanut Specific Immunoglobulin E (IgE) Levels

    Time frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    • To determine if a change exists in peanut specific Immunoglobulin E (IgE) levels

  3. Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels

    Time frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    • To determine if a change exists in peanut specific Immunoglobulin G4 (IgG4) levels

  4. Change in Peanut Skin Prick Test Mean Wheal Diameter

    Time frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    • To determine if a change exists in peanut skin prick test mean wheal diameter

  5. Change in Peanut Component Levels

    Time frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

    • To determine if a change exists in peanut component levels (peanut Ara h 2)

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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