Hookworm infestation as therapy in Crohn's disease

INTERVENTION: A dose of ten L3 larvae of Nicrophorus americanus pipetted in solution onto a gauze pad and administered onto the skin under sticking plaster. The placebo will consist of 2 µM of standard histamine solution, as used in skin prick testing, applied topically to the skin under a sealed dressing. This produces an itch lasting for approximately ten seconds. CONDITION: Crohn's disease ; Digestive System ; Crohn's disease PRIMARY OUTCOME: Change in the CDAI at week 12 SECONDARY OUTCOME: 1. Disease activity, measured by the Harvey Bradshaw Index (HBI); 2. Inflammatory markers (Erythrocyte Sedimentation Rate [ESR], C‐Reactive Protein [CRP]), platelet count; 3. Circulating Interleukin 2 (IL2) receptor and Interleukin 6 (IL6) levels (measured by Elisa) used as an index of efficacy as well as of a switch between Th1 and Th2 (T‐Helper cells) responsiveness; 4. Patients' global impression of change; 5. Cytokine profiles (IL2, Interleukin 4 [IL4], Interleukin 5 [IL5], Interleukin 10 [IL10], Transforming Growth Factor beta [TGF beta]) and gamma interferon from peripheral blood mononuclear cells measured by Elisa and measured conjunction to show evidence of a Th1/Th2 switch, and change in the Treg and Tr1 phenotype; 6. Quality of life, measured using the Inflammatory Bowel Disease Questionnaire (IBDQ); 7. Health status, measured using the EQ‐5D INCLUSION CRITERIA: 1. Diagnosis of moderately active Crohn's disease (CDAI between 220 and 450) requiring outpatient treatment 2. Clinically acceptable baseline screening tests 3. Aged between 18 and 80 4. Have given written informed consent