Hookworm infestation as therapy in Crohn's disease
| ISRCTN | ISRCTN48965919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48965919 |
| Secondary identifying numbers | Version 2.2, 23 March 2006 |
- Submission date
- 12/06/2006
- Registration date
- 04/08/2006
- Last edited
- 10/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christopher Hawkey
Scientific
Scientific
Wolfson Digestive Diseases Centre
C Floor
South Block
Nottingham University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Multicentre randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Hookworm infestation as therapy in Crohn's disease |
| Study objectives | 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(s) | Nottingham Research Ethics Committee, 07/11/2005, ref: 05/Q2403/144 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Change in the CDAI at week 12 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2006 |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham University Hospital
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research and Commercialisation Office
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
The Eli and Edythe L. Broad Foundation (reference number: BMRP proposal No. IBD-0184)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
