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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00671138




Registration number
NCT00671138
Ethics application status
Date submitted
1/05/2008
Date registered
5/05/2008
Date last updated
2/02/2016

Titles & IDs
Public title
Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus: Evaluating Immunity and Gluten-sensitivity
Scientific title
A Phase 2a, Randomized, Double Blinded, Placebo Controlled, Study Evaluating Immunity and Gluten-sensitivity by Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus.
Secondary ID [1] 0 0
IBD-0214R
Secondary ID [2] 0 0
2007/115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Necator americanus
Other interventions - Sham inoculation

Active comparator: I - Arm I will be inoculated with the human hookworm necator americanus at weeks 0 and 12.

Placebo comparator: II - Arm II participants will receive and identical sham-inoculums comprising a diluted amount of 0.2ml McIlhenny \& Co Tabasco Pepper Sauce®


Treatment: Other: Necator americanus
10 necator americanus larvae will be inoculated at week 0 with a further 5 larvae inoculated at week 12

Other interventions: Sham inoculation
A diluted amount of McIlhenny \& Co Tabasco Pepper Sauce will be applied via a gauze dressing at weeks 0 and 12.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duodenal histology (Marsh classification) and rectal histology
Timepoint [1] 0 0
21 weeks
Secondary outcome [1] 0 0
Peripheral blood mononuclear cells and mucosal lymphocytes will be grown ex vivo and challenged with gluten antigen immunodominant peptide. Cell proliferation and cytokine profiles will also be measured.
Timepoint [1] 0 0
21 weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Institute of Medical Research - Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Logan Hospital - Logan
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4131 - Logan

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Alexandra Hospital, Brisbane, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Broad Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Townsville Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
James Cook University, Queensland, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Walter and Eliza Hall Institute of Medical Research
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Queensland Institute of Medical Research
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John T Croese, FRACP MD
Address 0 0
The Townsville Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00671138