Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

Peter Bager; John Arnved; Steen Rønborg; Jan Wohlfahrt; Lars K. Poulsen; Tine Westergaard; Henning Willads Petersen; Bjarne Kristensen; Stig Milan Thamsborg; Allan Knud Roepstorff; Christian Moliin Outzen Kapel; Mads Melbye

doi:10.1016/j.jaci.2009.08.006

Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

Peter Bager, John Arnved, Steen Rønborg, Jan Wohlfahrt, Lars K. Poulsen, Tine Westergaard, Henning Willads Petersen, Bjarne Kristensen, Stig Milan Thamsborg, Allan Knud Roepstorff, Christian Moliin Outzen Kapel, Mads Melbye

143 Citationer (Scopus)

Abstract

Background: Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy for allergic disease, the helminth Trichuris suis has demonstrated efficacy in treatment of inflammatory bowel disease. Objective: To determine efficacy of helminth therapy for allergic rhinitis. Methods: We conducted a double-blind, placebo-controlled, parallel group trial in which 100 subjects age 18 to 65 years with grass pollen-induced allergic rhinitis were randomly assigned to ingest a total of 8 doses with 2500 live T suis ova or placebo with an interval of 21 days. The primary outcome was a change in mean daily total symptom score for runny, itchy, sneezing nose (maximum change, 9.0) or in percentage of well days during the grass pollen season. Results: Treatment with T suis ova (N = 49) compared with placebo (N = 47) caused transient diarrhea peaking at day 41 in 33% of participants (placebo, 2%), and increased eosinophil counts (P < .001) and T suis-specific IgE (P < .05), IgG (P < .001), IgG₄ (P < .003), and IgA (P < .001), whereas there was no significant change in symptom scores (0.0; 95% CI, -0.5 to 0.4; P = .87), well days (3%; 95% CI, -9% to 14%; P = .63), total histamine (P = .44), grass-specific IgE (P = .76), or diameter of wheal reaction on skin prick testing with grass (P = .85) or 9 other allergens. Conclusion: Repeated treatment with the helminth T suis induced a substantial clinical and immunologic response as evidence of infection, but had no therapeutic effect on allergic rhinitis.

Originalsprog	Engelsk
Tidsskrift	Journal of Allergy and Clinical Immunology
Vol/bind	125
Udgave nummer	1
Sider (fra-til)	123-130.e3
Antal sider	11
ISSN	0091-6749
DOI	https://doi.org/10.1016/j.jaci.2009.08.006
Status	Udgivet - jan. 2010

Emneord

Det tidligere LIFE
Allergic rhinitis
Trichuris suis
randomized clinical trial
parasite
helminth
allergy
IgE
skin prick test
total histamine
eosinophils

FN’s Verdensmål

Dette resultat bidrager til følgende verdensmål

Adgang til dokumentet

10.1016/j.jaci.2009.08.006

http://www.jacionline.org/article/S0091674909011816/pdf

Citationsformater

Bager, P., Arnved, J., Rønborg, S., Wohlfahrt, J., Poulsen, L. K., Westergaard, T., Petersen, H. W., Kristensen, B., Thamsborg, S. M., Roepstorff, A. K., Kapel, C. M. O., & Melbye, M. (2010). Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial. Journal of Allergy and Clinical Immunology, 125(1), 123-130.e3. https://doi.org/10.1016/j.jaci.2009.08.006

Bager, P, Arnved, J, Rønborg, S, Wohlfahrt, J, Poulsen, LK, Westergaard, T, Petersen, HW, Kristensen, B, Thamsborg, SM, Roepstorff, AK, Kapel, CMO & Melbye, M 2010, 'Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial', Journal of Allergy and Clinical Immunology, bind 125, nr. 1, s. 123-130.e3. https://doi.org/10.1016/j.jaci.2009.08.006

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title = "Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial",

abstract = "Background: Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy for allergic disease, the helminth Trichuris suis has demonstrated efficacy in treatment of inflammatory bowel disease. Objective: To determine efficacy of helminth therapy for allergic rhinitis. Methods: We conducted a double-blind, placebo-controlled, parallel group trial in which 100 subjects age 18 to 65 years with grass pollen-induced allergic rhinitis were randomly assigned to ingest a total of 8 doses with 2500 live T suis ova or placebo with an interval of 21 days. The primary outcome was a change in mean daily total symptom score for runny, itchy, sneezing nose (maximum change, 9.0) or in percentage of well days during the grass pollen season. Results: Treatment with T suis ova (N = 49) compared with placebo (N = 47) caused transient diarrhea peaking at day 41 in 33% of participants (placebo, 2%), and increased eosinophil counts (P < .001) and T suis-specific IgE (P < .05), IgG (P < .001), IgG4 (P < .003), and IgA (P < .001), whereas there was no significant change in symptom scores (0.0; 95% CI, -0.5 to 0.4; P = .87), well days (3%; 95% CI, -9% to 14%; P = .63), total histamine (P = .44), grass-specific IgE (P = .76), or diameter of wheal reaction on skin prick testing with grass (P = .85) or 9 other allergens. Conclusion: Repeated treatment with the helminth T suis induced a substantial clinical and immunologic response as evidence of infection, but had no therapeutic effect on allergic rhinitis.",

keywords = "Former LIFE faculty, Allergic rhinitis, Trichuris suis, randomized clinical trial, parasite, helminth, allergy, IgE, skin prick test, total histamine, eosinophils",

author = "Peter Bager and John Arnved and Steen R{\o}nborg and Jan Wohlfahrt and Poulsen, {Lars K.} and Tine Westergaard and Petersen, {Henning Willads} and Bjarne Kristensen and Thamsborg, {Stig Milan} and Roepstorff, {Allan Knud} and Kapel, {Christian Moliin Outzen} and Mads Melbye",

year = "2010",

month = jan,

doi = "10.1016/j.jaci.2009.08.006",

language = "English",

volume = "125",

pages = "123--130.e3",

journal = "Journal of Allergy and Clinical Immunology",

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TY - JOUR

T1 - Trichuris suis ova therapy for allergic rhinitis

T2 - a randomized, double-blind, placebo-controlled clinical trial

AU - Bager, Peter

AU - Arnved, John

AU - Rønborg, Steen

AU - Wohlfahrt, Jan

AU - Poulsen, Lars K.

AU - Westergaard, Tine

AU - Petersen, Henning Willads

AU - Kristensen, Bjarne

AU - Thamsborg, Stig Milan

AU - Roepstorff, Allan Knud

AU - Kapel, Christian Moliin Outzen

AU - Melbye, Mads

PY - 2010/1

Y1 - 2010/1

N2 - Background: Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy for allergic disease, the helminth Trichuris suis has demonstrated efficacy in treatment of inflammatory bowel disease. Objective: To determine efficacy of helminth therapy for allergic rhinitis. Methods: We conducted a double-blind, placebo-controlled, parallel group trial in which 100 subjects age 18 to 65 years with grass pollen-induced allergic rhinitis were randomly assigned to ingest a total of 8 doses with 2500 live T suis ova or placebo with an interval of 21 days. The primary outcome was a change in mean daily total symptom score for runny, itchy, sneezing nose (maximum change, 9.0) or in percentage of well days during the grass pollen season. Results: Treatment with T suis ova (N = 49) compared with placebo (N = 47) caused transient diarrhea peaking at day 41 in 33% of participants (placebo, 2%), and increased eosinophil counts (P < .001) and T suis-specific IgE (P < .05), IgG (P < .001), IgG4 (P < .003), and IgA (P < .001), whereas there was no significant change in symptom scores (0.0; 95% CI, -0.5 to 0.4; P = .87), well days (3%; 95% CI, -9% to 14%; P = .63), total histamine (P = .44), grass-specific IgE (P = .76), or diameter of wheal reaction on skin prick testing with grass (P = .85) or 9 other allergens. Conclusion: Repeated treatment with the helminth T suis induced a substantial clinical and immunologic response as evidence of infection, but had no therapeutic effect on allergic rhinitis.

AB - Background: Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy for allergic disease, the helminth Trichuris suis has demonstrated efficacy in treatment of inflammatory bowel disease. Objective: To determine efficacy of helminth therapy for allergic rhinitis. Methods: We conducted a double-blind, placebo-controlled, parallel group trial in which 100 subjects age 18 to 65 years with grass pollen-induced allergic rhinitis were randomly assigned to ingest a total of 8 doses with 2500 live T suis ova or placebo with an interval of 21 days. The primary outcome was a change in mean daily total symptom score for runny, itchy, sneezing nose (maximum change, 9.0) or in percentage of well days during the grass pollen season. Results: Treatment with T suis ova (N = 49) compared with placebo (N = 47) caused transient diarrhea peaking at day 41 in 33% of participants (placebo, 2%), and increased eosinophil counts (P < .001) and T suis-specific IgE (P < .05), IgG (P < .001), IgG4 (P < .003), and IgA (P < .001), whereas there was no significant change in symptom scores (0.0; 95% CI, -0.5 to 0.4; P = .87), well days (3%; 95% CI, -9% to 14%; P = .63), total histamine (P = .44), grass-specific IgE (P = .76), or diameter of wheal reaction on skin prick testing with grass (P = .85) or 9 other allergens. Conclusion: Repeated treatment with the helminth T suis induced a substantial clinical and immunologic response as evidence of infection, but had no therapeutic effect on allergic rhinitis.

KW - Former LIFE faculty

KW - Allergic rhinitis

KW - Trichuris suis

KW - randomized clinical trial

KW - parasite

KW - helminth

KW - allergy

KW - IgE

KW - skin prick test

KW - total histamine

KW - eosinophils

U2 - 10.1016/j.jaci.2009.08.006

DO - 10.1016/j.jaci.2009.08.006

M3 - Journal article

C2 - 19800680

SN - 0091-6749

VL - 125

SP - 123-130.e3

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 1

ER -

Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

Abstract

Emneord

FN’s Verdensmål

Adgang til dokumentet

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Citationsformater