NCT05138757

Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Completed Phase 1, PHASE2 Results posted Last updated 9 March 2026

What this trial tests

Phase 1, PHASE2 trial testing Prebiotic in Peanut Allergy in 20 participants. Completed in 12 March 2025.

Timeline

30 November 2021

Primary endpoint
12 March 2025

12 March 2025

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Enrollment	20
Start date	30 November 2021
Primary completion	12 March 2025
Estimated completion	12 March 2025
Sites	2 locations across United States

Drugs / interventions tested

• Prebiotic — full drug profile →
• Placebo

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

University of Chicago

Who can join

Adults 4 to 17, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Fiber	4
Placebo	4

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

Group	Value	95% CI
Fiber	4
Placebo	7

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

Group	Value	95% CI
Fiber	3
Placebo	5

Fecal Butyrate Concentration (mM) Secondary · 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).

Baseline

Group	Value	95% CI
Fiber	18.45	± 12.25
Placebo	21.02	± 13.47

Visit 4 (After 1 month of fiber or placebo supplementation)

Group	Value	95% CI
Fiber	15.64	± 12.30
Placebo	15.94	± 9.98

Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)

Group	Value	95% CI
Fiber	20.80	± 24.15
Placebo	18.55	± 21.52

Change from baseline (week 4)

Group	Value	95% CI
Fiber	-5.93	± 17.67
Placebo	-6.37	± 15.31

Change from baseline (week 16)

Group	Value	95% CI
Fiber	-1.51	± 21.42
Placebo	-3.31	± 25.29

Change in Peanut Specific Immunoglobulin E (IgE) Levels Secondary · 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

Baseline

Group	Value	95% CI
Fiber	17.31	± 18.93
Placebo	69.34	± 41.58

Visit 4 (After 1 month of fiber or placebo supplementation)

Group	Value	95% CI
Fiber	25.21	± 32.31
Placebo	73.55	± 39.94

Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)

Group	Value	95% CI
Fiber	12.47	± 18.90
Placebo	57.72	± 38.17

Change from baseline (visit 4)

Group	Value	95% CI
Fiber	7.89	± 18.86
Placebo	4.21	± 17.03

Change from baseline (visit 16)

Group	Value	95% CI
Fiber	-2.01	± 3.12
Placebo	-10.85	± 28.61

Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels Secondary · 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

Baseline

Group	Value	95% CI
Fiber	0.41	± 0.20
Placebo	1.58	± 1.98

Visit 4 (After 1 month of fiber or placebo supplementation)

Group	Value	95% CI
Fiber	0.57	± 0.40
Placebo	2.21	± 3.33

Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)

Group	Value	95% CI
Fiber	2.20	± 2.25
Placebo	8.31	± 8.78

Change from Baseline (Visit 4)

Group	Value	95% CI
Fiber	0.09	± 0.20
Placebo	0.54	± 1.30

Change from Baseline (Visit 16)

Group	Value	95% CI
Fiber	1.84	± 2.23
Placebo	8.61	± 8.81

Change in Peanut Skin Prick Test Mean Wheal Diameter Secondary · 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

Baseline

Group	Value	95% CI
Fiber	15.00	± 5.07
Placebo	16.73	± 11.16

Visit 4 (After 1 month of fiber or placebo supplementation)

Group	Value	95% CI
Fiber	18.67	± 18.84
Placebo	18.00	± 14.12

Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)

Group	Value	95% CI
Fiber	5.20	± 3.63
Placebo	6.78	± 3.70

Change from Baseline (Visit 4)

Group	Value	95% CI
Fiber	3.67	± 15.26
Placebo	1.27	± 16.20

Change from Baseline (Visit 16)

Group	Value	95% CI
Fiber	-12.80	± 3.27
Placebo	-11.89	± 8.97

Change in Peanut Component Levels Secondary · 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)

Baseline

Group	Value	95% CI
Fiber	12.91	± 19.01
Placebo	59.43	± 40.20

Visit 4 (After 1 month of fiber or placebo supplementation)

Group	Value	95% CI
Fiber	22.62	± 33.86
Placebo	66.61	± 39.97

Visit 16 (At the exit double-blind, placebo-controlled oral food challenge)

Group	Value	95% CI
Fiber	13.99	± 27.97
Placebo	45.41	± 33.79

Change from Baseline (Visit 4)

Group	Value	95% CI
Fiber	9.71	± 26.81
Placebo	7.18	± 13.57

Change from Baseline (Visit 16)

Group	Value	95% CI
Fiber	-0.17	± 3.16
Placebo	-9.53	± 18.74

Adverse events — posted to ClinicalTrials.gov

Time frame: From first study intervention through the final exit food challenge visit, up to 15 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fiber

Serious: 0/9 (0%)

Deaths: 0/9

Placebo

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (25 terms — click to expand)

Reaction	System	Fiber	Placebo
Rash	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Oropharyngeal discomfort	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Fever	General disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Upper respiratory infection	Infections and infestations	—	—
Angioedema	Skin and subcutaneous tissue disorders	—	—
Sore throat	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—
Mouth pain	Skin and subcutaneous tissue disorders	—	—
Fatigue	General disorders	—	—
Car accident	Injury, poisoning and procedural complications	—	—
Ear pain	Ear and labyrinth disorders	—	—
Anxiety	Psychiatric disorders	—	—
Viral conjunctivitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Allergic reaction to food	Immune system disorders	—	—

Data from ClinicalTrials.gov NCT05138757 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feast for thought: A comprehensive review of food allergy 2021-2023.
   Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
2. The Role of Biologics in the Treatment of Food Allergy.
   Sindher SB, Fiocchi A, Zuberbier T, Arasi S, et al · · 2024 · cited 21× · PMID 38013157 · DOI 10.1016/j.jaip.2023.11.032
3. Commensal collaborations: Food allergy and the microbiome.
   Arditi Z, Bunyavanich S. · · 2023 · cited 10× · PMID 37558058 · DOI 10.1016/j.jaci.2023.08.001
4. Microbiome Therapeutics for Food Allergy.
   Chernikova DA, Zhao MY, Jacobs JP. · · 2022 · cited 8× · PMID 36501184 · DOI 10.3390/nu14235155
5. The Etiology of IgE-Mediated Food Allergy: Potential Therapeutics and Challenges.
   Carnazza M, Werner R, Tiwari RK, Geliebter J, et al · · 2025 · cited 3× · PMID 40004029 · DOI 10.3390/ijms26041563