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 Thamsborg; Allan Roepstorff; Christian 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 Thamsborg, Allan Roepstorff, Christian Kapel, Mads Melbye

143 Citations (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.

Original language	English
Journal	Journal of Allergy and Clinical Immunology
Volume	125
Issue number	1
Pages (from-to)	123-30.e1-3
ISSN	0091-6749
DOIs	https://doi.org/10.1016/j.jaci.2009.08.006
Publication status	Published - 1 Jan 2010

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10.1016/j.jaci.2009.08.006

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Bager, P., Arnved, J., Rønborg, S., Wohlfahrt, J., Poulsen, L. K., Westergaard, T., Petersen, H. W., Kristensen, B., Thamsborg, S., Roepstorff, A., Kapel, C., & 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), 123-30.e1-3. 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, S, Roepstorff, A, Kapel, C & Melbye, M 2010, 'Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial', Journal of Allergy and Clinical Immunology, vol. 125, no. 1, pp. 123-30.e1-3. 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.",

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 Stig Thamsborg and Allan Roepstorff and Christian Kapel and Mads Melbye",

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language = "English",

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T1 - Trichuris suis ova therapy for allergic rhinitis: 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

AU - Roepstorff, Allan

AU - Kapel, Christian

AU - Melbye, Mads

PY - 2010/1/1

Y1 - 2010/1/1

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.

U2 - 10.1016/j.jaci.2009.08.006

DO - 10.1016/j.jaci.2009.08.006

M3 - Journal article

SN - 0091-6749

VL - 125

SP - 123-30.e1-3

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

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