Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2.2, 23 March 2006
Study information
Scientific title
Hookworm infestation as therapy in Crohn's disease
Acronym
Study hypothesis
Does a single dose of hookworm larvae reduce disease activity in Crohn's Disease (CD) (as measured by the Crohn's Disease Activity Index [CDAI], biochemical markers of severity) compared to placebo?
Ethics approval
Nottingham Research Ethics Committee, 07/11/2005, ref: 05/Q2403/144
Study design
Multicentre randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure will be change in the CDAI at week 12.
Secondary outcome measures
1. Disease activity by 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) will be 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 - Inflammatory Bowel Disease Questionnaire (IBDQ)
7. EQ-5D - this is a measure of health status for use in evaluating health and healthcare
Overall trial start date
01/02/2006
Overall trial end date
31/01/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
31/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Digestive Diseases Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research and Commercialisation Office
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Eli and Edythe L. Broad Foundation (reference number: BMRP proposal No. IBD-0184)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary