Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

NCT05138757 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB21-0589
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

oral immunotherapy; fiber; Peanut; anaphylaxis; allergy; pediatrics; prebiotic; food allergy; microbiome; probiotic

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

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

  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

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

Other Outcomes (5)

• Fecal Butyrate Concentration (mM)

  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

  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

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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Prebiotic DRUG

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

Treatment Group

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

University of Chicago- Department of Pediatrics

Hyde Park, Illinois, 60637, United States

Location

Related Publications (14)

• Gupta RS, Warren CM, Smith BM, et al. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. 2018:142(6):e20181235. Pediatrics. 2019 Mar;143(3):e20183835. doi: 10.1542/peds.2018-3835. No abstract available.

  PMID: 30819972 BACKGROUND

• Primeau MN, Kagan R, Joseph L, Lim H, Dufresne C, Duffy C, Prhcal D, Clarke A. The psychological burden of peanut allergy as perceived by adults with peanut allergy and the parents of peanut-allergic children. Clin Exp Allergy. 2000 Aug;30(8):1135-43. doi: 10.1046/j.1365-2222.2000.00889.x.

  PMID: 10931121 BACKGROUND

• Lieberman JA, Gupta RS, Knibb RC, Haselkorn T, Tilles S, Mack DP, Pouessel G. The global burden of illness of peanut allergy: A comprehensive literature review. Allergy. 2021 May;76(5):1367-1384. doi: 10.1111/all.14666. Epub 2021 Jan 16.

  PMID: 33216994 BACKGROUND

• PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.

  PMID: 30449234 BACKGROUND

• Anagnostou K, Islam S, King Y, Foley L, Pasea L, Bond S, Palmer C, Deighton J, Ewan P, Clark A. Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial. Lancet. 2014 Apr 12;383(9925):1297-1304. doi: 10.1016/S0140-6736(13)62301-6. Epub 2014 Jan 30.

  PMID: 24485709 BACKGROUND

• Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group. Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.

  PMID: 29092786 BACKGROUND

• Anagnostou K, Clark A. The management of peanut allergy. Arch Dis Child. 2015 Jan;100(1):68-72. doi: 10.1136/archdischild-2014-306152. Epub 2014 Aug 25.

  PMID: 25157179 BACKGROUND

• Bunyavanich S, Berin MC. Food allergy and the microbiome: Current understandings and future directions. J Allergy Clin Immunol. 2019 Dec;144(6):1468-1477. doi: 10.1016/j.jaci.2019.10.019.

  PMID: 31812181 BACKGROUND

• Baxter NT, Schmidt AW, Venkataraman A, Kim KS, Waldron C, Schmidt TM. Dynamics of Human Gut Microbiota and Short-Chain Fatty Acids in Response to Dietary Interventions with Three Fermentable Fibers. mBio. 2019 Jan 29;10(1):e02566-18. doi: 10.1128/mBio.02566-18.

  PMID: 30696735 BACKGROUND

• Feehley T, Plunkett CH, Bao R, Choi Hong SM, Culleen E, Belda-Ferre P, Campbell E, Aitoro R, Nocerino R, Paparo L, Andrade J, Antonopoulos DA, Berni Canani R, Nagler CR. Healthy infants harbor intestinal bacteria that protect against food allergy. Nat Med. 2019 Mar;25(3):448-453. doi: 10.1038/s41591-018-0324-z. Epub 2019 Jan 14.

  PMID: 30643289 BACKGROUND

• Tan J, McKenzie C, Vuillermin PJ, Goverse G, Vinuesa CG, Mebius RE, Macia L, Mackay CR. Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect against Food Allergy through Diverse Cellular Pathways. Cell Rep. 2016 Jun 21;15(12):2809-24. doi: 10.1016/j.celrep.2016.05.047.

  PMID: 27332875 BACKGROUND

• Lejk A, Mysliwiec M, Mysliwiec A. Effect of eating resistant starch on the development of overweight, obesity,and disorders of carbohydrate metabolism in children. Pediatr Endocrinol Diabetes Metab. 2019;25(2):81-84. doi: 10.5114/pedm.2019.85818.

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• Montroy J, Berjawi R, Lalu MM, Podolsky E, Peixoto C, Sahin L, Stintzi A, Mack D, Fergusson DA. The effects of resistant starches on inflammatory bowel disease in preclinical and clinical settings: a systematic review and meta-analysis. BMC Gastroenterol. 2020 Nov 10;20(1):372. doi: 10.1186/s12876-020-01516-4.

  PMID: 33167889 BACKGROUND

• Sanders LM, Dicklin MR, Palacios OM, Maki CE, Wilcox ML, Maki KC. Effects of potato resistant starch intake on insulin sensitivity, related metabolic markers and appetite ratings in men and women at risk for type 2 diabetes: a pilot cross-over randomised controlled trial. J Hum Nutr Diet. 2021 Feb;34(1):94-105. doi: 10.1111/jhn.12822. Epub 2020 Oct 29.

  PMID: 33119948 BACKGROUND

MeSH Terms

Conditions

Peanut Hypersensitivity; Anaphylaxis; Hypersensitivity; Food Hypersensitivity

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Limitations and Caveats

The study enrolled a limited number of participants, which reduced statistical power and may have limited the ability to detect the effect of the intervention.

Results Point of Contact

• Title: So Lim Kim
• Organization: University of Chicago

solim.kim@bsd.uchicago.edu

7738347913

Study Officials

• Christina E Ciaccio, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: December 1, 2021
• Study Start: November 30, 2021
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)