Condition category
Digestive System
Date applied
12/06/2006
Date assigned
04/08/2006
Last edited
09/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Hawkey

ORCID ID

Contact details

Wolfson Digestive Diseases Centre
C Floor
South Block
Nottingham University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

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

http://www.nottingham.ac.uk

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

Publication citations

Additional files

Editorial Notes