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Fiber fix for peanut allergy? small study tests prebiotic boost to OIT

NCT ID NCT05138757

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested whether adding a prebiotic fiber (a type of plant fiber found in grocery stores) to peanut oral immunotherapy could help children aged 4 to 17 with peanut allergy tolerate more peanut protein with fewer side effects. Twenty children participated, and the study looked at safety and how many could eat at least 2044 mg of peanut protein with only mild symptoms after 12 months. The results are preliminary and need larger studies to confirm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prebiotic fiber
What this could lead to
If it works, this could point toward a way to make peanut oral immunotherapy safer and more effective by adding a simple dietary fiber.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply broadly. The prebiotic is not FDA-approved for this use, and side effects like stomach issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

20 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Comer Children's Hospital

    Chicago, Illinois, 60637, United States

  • University of Chicago- Department of Pediatrics

    Hyde Park, Illinois, 60637, United States

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