Crohn's disease Digestive System Crohn's disease
Conditions
Interventions
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 so
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Positive stool culture for enteric pathogens or Clostridium difficile 2. Bowel perforation, or obstructive symptoms not due substantially to active inflammation 3. Patients whose diarrhoea is believed to be due to short bowel syndrome or bile salt malabsorption (making the CDAI invalid) 4. Female patients of child bearing potential who are not willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined oral contraceptives, sexual abstinence or vastectomised partner 5. Concomitant immunosuppressive therapy (cyclosporin in the last three months, methotrexate in the last six months, prednisolone more than 10 mg/day) or infliximab in the past three months. Azathioprine is permitted if the patient has been on a stable dose for at least two months 6. Serious intercurrent infection or other active disease up to three months prior to treatment 7. Known Human Immunodieficiency Virus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the CDAI at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed