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Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis

NCT00232518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-05-07

No results posted yet for this study

Summary

There has been considerable debate over the last 30 years about the interaction between asthma and parasitic infection. It has been suggested that at least part of the reason for the increasing prevalence of asthma in the developed world is a decrease in parasite infections resulting from improved living conditions with economic development. Our previous studies in Ethiopia suggest that hookworm infection may be particularly important in this process.

To establish definitively whether parasites can protect against allergic disease, and specifically asthma, ultimately requires a randomised clinical trial of parasite infection in patients with asthma. We, the researchers at the University of Nottingham, have completed a study in normal volunteers to establish the dose of hookworms necessary to generate infection at the level shown to be protective in population surveys, and shown that infection is well tolerated. We now propose two randomised placebo-controlled double blind clinical trials. The first will test the effectiveness of hookworm infection in reducing symptoms in allergic patients with rhinitis, and will also serve to allow us to check the likely safety of hookworm infection in asthma. Assuming that the results of this study are favourable, we will then carry out a trial of hookworm infection in asthma. We will also take the opportunity during both of these studies to investigate the cellular mechanisms of the effect of hookworm infection on the immune system.

Conditions

  • Rhinitis, Allergic, Perennial
  • Hayfever
  • Allergy

Interventions

PROCEDURE

Infection with hookworm larvae

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • John Britton · University of Nottingham

  • David Prichard · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2006-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00232518 on ClinicalTrials.gov