Study Summary
This trial is testing whether adding a prebiotic to peanut oral immunotherapy is safe and effective. The prebiotic is a type of fiber found in grocery stores, not an FDA-approved drug.
Eligible Conditions
- Peanut Allergy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Within 4 years
Within 4 years
Change in Peanut skin prick test mean wheal diameter
Change in peanut component levels
Change in peanut specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) levels
The effect of a prebiotic on fecal microbiome and metabolome
The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
The proportion of subjects who experience dose related GI side effects during oral immunotherapy
The proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Treatment Group
1 of 2
Control Group
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Prebiotic · Has Placebo Group · Phase 1 & 2
Treatment Group
Drug
Experimental Group · 1 Intervention: Prebiotic · Intervention Types: DrugControl Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prebiotic
2016
Completed Phase 2
~630
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 4 years
Who is running the clinical trial?
University of ChicagoLead Sponsor
927 Previous Clinical Trials
753,982 Total Patients Enrolled
Christina E Ciaccio, MDPrincipal InvestigatorUniversity of Chicago
Eligibility Criteria
Age 4 - 17 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a positive skin test to peanut and/or a positive serum IgE to peanut.
You are above the age of 7 years.\n
You have an immune response to peanut proteins.
You have a serum IgE to peanut of at least 0.
You have a positive skin test to peanut and a positive serum IgE to peanut of >5 kUA/L.
You have a history of symptoms consistent with peanut allergy and you have a positive skin prick test to peanut protein.
References
- Bunyavanich, Supinda, and M. Cecilia Berin. 2019. “Food Allergy and the Microbiome: Current Understandings and Future Directions”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2019.10.019.
- Baxter, Nielson T., Alexander W. Schmidt, Arvind Venkataraman, Kwi S. Kim, Clive Waldron, and Thomas M. Schmidt. 2019. “Dynamics of Human Gut Microbiota and Short-chain Fatty Acids in Response to Dietary Interventions with Three Fermentable Fibers”. Edited by Martin J. Blaser. Mbio. American Society for Microbiology. doi:10.1128/mbio.02566-18.
- Primeau, Kagan, Joseph, Lim, Dufresne, Duffy, Prhcal, and Clarke. 2000. “The Psychological Burden of Peanut Allergy as Perceived by Adults with Peanut Allergy and the Parents of Peanut-allergic Children”. Clinical & Experimental Allergy. Wiley. doi:10.1046/j.1365-2222.2000.00889.x.
- The PALISADE Group of Clinical Investigators. 2018. “AR101 Oral Immunotherapy for Peanut Allergy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1812856.
- Bird, J. Andrew, Jonathan M. Spergel, Stacie M. Jones, Rima Rachid, Amal H. Assa'ad, Julie Wang, Stephanie A. Leonard, et al.. 2018. “Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Trial”. The Journal of Allergy and Clinical Immunology: In Practice. Elsevier BV. doi:10.1016/j.jaip.2017.09.016.
- Montroy, Joshua, Rania Berjawi, Manoj M. Lalu, Eyal Podolsky, Cayden Peixoto, Levent Sahin, Alain Stintzi, David Mack, and Dean A. Fergusson. 2020. “The Effects of Resistant Starches on Inflammatory Bowel Disease in Preclinical and Clinical Settings: A Systematic Review and Meta-analysis”. BMC Gastroenterology. Springer Science and Business Media LLC. doi:10.1186/s12876-020-01516-4.
- “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”. 2019. “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. American Academy of Pediatrics (AAP). doi:10.1542/peds.2018-3835.
- Tan, Jian, Craig McKenzie, Peter J. Vuillermin, Gera Goverse, Carola G. Vinuesa, Reina E. Mebius, Laurence Macia, and Charles R. Mackay. 2016. “Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect Against Food Allergy Through Diverse Cellular Pathways”. Cell Reports. Elsevier BV. doi:10.1016/j.celrep.2016.05.047.
- Sanders, L. M., M. R. Dicklin, O. M. Palacios, C. E. Maki, M. L. Wilcox, and K. C. Maki. 2020. “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”. Journal of Human Nutrition and Dietetics. Wiley. doi:10.1111/jhn.12822.
- Lejk, Agnieszka, Małgorzata Myśliwiec, and Artur Myśliwiec. 2019. “Effect of Eating Resistant Starch on the Development of Overweight, Obesity,and Disorders of Carbohydrate Metabolism in Children”. Pediatric Endocrinology Diabetes and Metabolism. Termedia Sp. z.o.o.. doi:10.5114/pedm.2019.85818.
- Anagnostou, Katherine, and Andrew Clark. 2014. “The Management of Peanut Allergy”. Archives of Disease in Childhood. BMJ. doi:10.1136/archdischild-2014-306152.
- Lieberman, Jay A., Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. 2021. “The Global Burden of Illness of Peanut Allergy: A Comprehensive Literature Review”. Allergy. Wiley. doi:10.1111/all.14666.
- Feehley, Taylor, Catherine H. Plunkett, Riyue Bao, Sung Min Choi Hong, Elliot Culleen, Pedro Belda-Ferre, Evelyn Campbell, et al.. 2019. “Healthy Infants Harbor Intestinal Bacteria That Protect Against Food Allergy”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-018-0324-z.
- Anagnostou, Katherine, Sabita Islam, Yvonne King, Loraine Foley, Laura Pasea, Simon Bond, Chris Palmer, John Deighton, Pamela Ewan, and Andrew Clark. 2014. “Assessing the Efficacy of Oral Immunotherapy for the Desensitisation of Peanut Allergy in Children (STOP II): A Phase 2 Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(13)62301-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2021. "Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05138757.
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