Status:
COMPLETED
Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus: Evaluating Immunity and Gluten-sensitivity
Lead Sponsor:
Princess Alexandra Hospital, Brisbane, Australia
Collaborating Sponsors:
The Broad Foundation
Townsville Hospital
Conditions:
Celiac Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The disappearance of intestinal parasites from humans in developed countries may be responsible for the upsurge in many diseases including Celiac Disease, Crohn's, ulcerative colitis, asthma and hay f...
Detailed Description
Background and aims: A number of lines of evidence suggest that the disappearance of helminths from human populations in developed countries may be responsible for the upsurge in autoimmune diseases, ...
Eligibility Criteria
Inclusion
- Diagnosis of celiac disease
- Positive tTG (IgA)or positive anti IgA gliadin or anti-endomysial antibody test.
- Marsh score ≥3 on small bowel biopsy (subtotal villous atrophy)
- Clinical, biochemical or histological improvement on gluten free diet.
- Compliance with a gluten-free diet for 6 months lead-in.
- Lifestyle \& travel history indicative of a low risk for helminthic infection.
- Good general health not on immunomodifying agents.
- Ability to complete study
- Understand study \& risks
- Social supports
- Workplace flexibility
- Normal tTG at enrollment (\<10 dependent on serology)
- A HLA-DQ2 phenotype
- Negative fecal test for intestinal helminthes.
- Negative serological test for anti-strongyloides antibodies
Exclusion
- Children (age \< 18)
- Immunomodulating medication in 6 months pre-enrollment
- Oral or intramuscular/intravascular steroids
- Regular weekly use of aspirin
- Regular weekly use of NSAID
- Regular weekly use of COXII inhibitors
- Regular weekly use of statin medications
- Clinical history indicating a likely need to use an immune suppressive agent during the course of the study.
- Unmanaged risk of pregnancy
- Past history of infection with helminthes (other than a past history of infection with the pinworm, Enterobius vermicularis)
- History of insulin dependent diabetes mellitus or Addison's disease
- History of anaphylaxis or severe allergic reactions
- Having received a vaccine within the preceding 30 days
- Positive strongyloides serology
- Iron deficiency anemia
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00671138
Start Date
October 1 2007
End Date
September 1 2009
Last Update
February 2 2016
Active Locations (3)
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1
Queensland Institute of Medical Research
Brisbane, Queensland, Australia, 4006
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
3
Logan Hospital
Logan City, Queensland, Australia, 4131