A Phase 1/2 interventional study of Prebiotic and Placebo in Peanut Allergy, sponsored by University of Chicago. Completed at 2 sites in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by University of Chicago · Phase 1/2, Interventional, and Prevention
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.
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Immune markers consistent with peanut allergy
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Prebiotic
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.
Drug: Placebo
A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.
A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.
The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC
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.
Time frame: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy
• To determine 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.
The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy
• To determine 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.
Fecal Butyrate Concentration (mM)
Fecal samples were collected at each study time point and analyzed for butyrate concentration using metabolomic profiling. Results are reported in millimolar (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).
Change in Peanut Specific Immunoglobulin E (IgE) Levels
• To determine if a change exists 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).
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
• To determine if a change exists 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).
Change in Peanut Skin Prick Test Mean Wheal Diameter
• To determine if a change exists 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).
Change in Peanut Component Levels
• To determine if a change exists in peanut component levels (peanut Ara h 2)
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).
Subjects were screened and enrolled at the University of Chicago.
| Milestone | Fiber | Placebo |
|---|---|---|
| Started | 9 | 11 |
| Completed | 5 | 9 |
| Not completed | 4 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 |
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.
| Participants | Fiber | Placebo |
|---|---|---|
| The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC | 4 | 4 |
• To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy.
| Participants | Fiber | Placebo |
|---|---|---|
| The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy | 4 | 7 |
• To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
| Participants | Fiber | Placebo |
|---|---|---|
| The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy | 3 | 5 |
Fecal samples were collected at each study time point and analyzed for butyrate concentration using metabolomic profiling. Results are reported in millimolar (mM).
| mM | Fiber | Placebo |
|---|---|---|
| Baseline | 18.45 ± 12.25 | 21.02 ± 13.47 |
| Visit 4 (After 1 month of fiber or placebo supplementation) | 15.64 ± 12.30 | 15.94 ± 9.98 |
| Visit 16 (At the exit double-blind, placebo-controlled oral food challenge) | 20.80 ± 24.15 | 18.55 ± 21.52 |
| Change from baseline (week 4) | -5.93 ± 17.67 | -6.37 ± 15.31 |
| Change from baseline (week 16) | -1.51 ± 21.42 | -3.31 ± 25.29 |
• To determine if a change exists in peanut specific Immunoglobulin E (IgE) levels
| kUA/L | Fiber | Placebo |
|---|---|---|
| Baseline | 17.31 ± 18.93 | 69.34 ± 41.58 |
| Visit 4 (After 1 month of fiber or placebo supplementation) | 25.21 ± 32.31 | 73.55 ± 39.94 |
| Visit 16 (At the exit double-blind, placebo-controlled oral food challenge) | 12.47 ± 18.90 | 57.72 ± 38.17 |
| Change from baseline (visit 4) | 7.89 ± 18.86 | 4.21 ± 17.03 |
| Change from baseline (visit 16) | -2.01 ± 3.12 | -10.85 ± 28.61 |
• To determine if a change exists in peanut specific Immunoglobulin G4 (IgG4) levels
| kUA/L | Fiber | Placebo |
|---|---|---|
| Baseline | 0.41 ± 0.20 | 1.58 ± 1.98 |
| Visit 4 (After 1 month of fiber or placebo supplementation) | 0.57 ± 0.40 | 2.21 ± 3.33 |
| Visit 16 (At the exit double-blind, placebo-controlled oral food challenge) | 2.20 ± 2.25 | 8.31 ± 8.78 |
| Change from Baseline (Visit 4) | 0.09 ± 0.20 | 0.54 ± 1.30 |
| Change from Baseline (Visit 16) | 1.84 ± 2.23 | 8.61 ± 8.81 |
• To determine if a change exists in peanut skin prick test mean wheal diameter
| mm | Fiber | Placebo |
|---|---|---|
| Baseline | 15.00 ± 5.07 | 16.73 ± 11.16 |
| Visit 4 (After 1 month of fiber or placebo supplementation) | 18.67 ± 18.84 | 18.00 ± 14.12 |
| Visit 16 (At the exit double-blind, placebo-controlled oral food challenge) | 5.20 ± 3.63 | 6.78 ± 3.70 |
| Change from Baseline (Visit 4) | 3.67 ± 15.26 | 1.27 ± 16.20 |
| Change from Baseline (Visit 16) | -12.80 ± 3.27 | -11.89 ± 8.97 |
• To determine if a change exists in peanut component levels (peanut Ara h 2)
| kUA/L | Fiber | Placebo |
|---|---|---|
| Baseline | 12.91 ± 19.01 | 59.43 ± 40.20 |
| Visit 4 (After 1 month of fiber or placebo supplementation) | 22.62 ± 33.86 | 66.61 ± 39.97 |
| Visit 16 (At the exit double-blind, placebo-controlled oral food challenge) | 13.99 ± 27.97 | 45.41 ± 33.79 |
| Change from Baseline (Visit 4) | 9.71 ± 26.81 | 7.18 ± 13.57 |
| Change from Baseline (Visit 16) | -0.17 ± 3.16 | -9.53 ± 18.74 |
Collected over From first study intervention through the final exit food challenge visit, up to 15 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fiber | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 8/11 (72.7%) |
| Event | Fiber | Placebo |
|---|---|---|
| RashSkin and subcutaneous tissue disorders | 3/9 | 4/11 |
| VomitingGastrointestinal disorders | 1/9 | 4/11 |
| ConstipationGastrointestinal disorders | 0/9 | 3/11 |
| Abdominal painGastrointestinal disorders | 2/9 | 3/11 |
| Oropharyngeal discomfortGastrointestinal disorders | 2/9 | 3/11 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/9 | 3/11 |
| FeverGeneral disorders | 2/9 | 3/11 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/9 | 3/11 |
| Upper respiratory infectionInfections and infestations | 1/9 | 3/11 |
| AngioedemaSkin and subcutaneous tissue disorders | 1/9 | 2/11 |
The baseline analysis population included all 20 enrolled participants. This population is identical to the participants assigned to the study arms in the Participant Flow.
| Age, Customized(Participants) | Fiber | Placebo | Total |
|---|---|---|---|
| Age — 4-6 years | 1 | 6 | 7 |
| Age — 7-9 years | 2 | 0 | 2 |
| Age — 10-12 years | 1 | 3 | 4 |
| Age — 13-15 years | 3 | 1 | 4 |
| Age — 16-17 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | Fiber | Placebo | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 5 | 7 | 12 |
| Race/Ethnicity, Customized(Participants) | Fiber | Placebo | Total |
|---|---|---|---|
| Race — White | 6 | 7 | 13 |
| Race — Black or African American | 2 | 2 | 4 |
| Race — Asian | 1 | 0 | 1 |
| Race — More than one race | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Fiber | Placebo | Total |
|---|---|---|---|
| United States | 9 | 11 | 20 |
| Peanut skin prick test wheal size(mm) | Fiber | Placebo | Total |
|---|---|---|---|
| Mean | 15.0 ± 5.07 | 16.73 ± 11.16 | 15.95 ± 8.78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2021 to primary completion in Mar 2025, 39 months.
Results were first posted in Mar 2026, 11 months after primary completion.
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Studies of the drug tested here: Prebiotics