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

• Published in: Journal of allergy and clinical immunology Vol. 125; no. 1; pp. 123 - 130.e3
• Main Authors: Bager, Peter, PhD, Arnved, John, MD, Rønborg, Steen, PhD, Wohlfahrt, Jan, PhD, Poulsen, Lars K., PhD, Westergaard, Tine, PhD, Petersen, Henning Willads, PharmD, Kristensen, Bjarne, MSc, Thamsborg, Stig, PhD, Roepstorff, Allan, PhD, Kapel, Christian, PhD, Melbye, Mads, DMSc
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 2010; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; Aged; Allergic rhinitis; Allergies; allergy; Allergy and Immunology; Animals; Antibodies, Helminth - blood; Biological and medical sciences; Clinical trials; Cytokines; Denmark; Desensitization, Immunologic; Disease; Double-Blind Method; eosinophils; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Good Manufacturing Practice; helminth; Humans; Hypotheses; IgE; Immunoglobulin E - blood; Immunopathology; Infections; Inflammatory bowel disease; Lymphocytes; Male; Medical sciences; Middle Aged; Non tumoral diseases; Otorhinolaryngology. Stomatology; Ovum - immunology; parasite; Parasites; Poaceae - immunology; Pollen - immunology; randomized clinical trial; Rhinitis, Allergic, Seasonal - etiology; Rhinitis, Allergic, Seasonal - immunology; Rhinitis, Allergic, Seasonal - physiopathology; Rhinitis, Allergic, Seasonal - therapy; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; skin prick test; Studies; Substance abuse treatment; total histamine; Treatment Outcome; Trichuris - growth & development; Trichuris - immunology; Trichuris suis; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Young Adult; Denmark; Trichuris suis; NO; Excretory-secretory; IgE; randomized clinical trial; allergy; eosinophils; mgA/L; ES; TSO; parasite; Allergic rhinitis; total histamine; Nitric oxide; SPT; skin prick test; helminth; Milligrams Trichuris suis–specific antibodies per liter serum; Trichuris suis ova; Allergy; Nose disease; Prick test; Rhinitis; Granulocyte; Randomization; Immunology; ENT disease; Clinical trial; Skin test; Immunopathology; Parasite; Exploration; Parasitosis; Eosinophil; Infection; Histamine; Treatment; Double blind study; Helmintha; Invertebrata
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2009.08.006

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.