Hookworm Therapy for Coeliac Disease (NCT02754609) | Clinical Trial Compass
CompletedPhase 1
Hookworm Therapy for Coeliac Disease
Australia, New Zealand54 participantsStarted 2016-09
Plain-language summary
This trial is a Phase 1b multicentre, multinational, randomized, double-blind with single-blind arm and open label extension phase, placebo controlled, clinical trial evaluating the safety and predictability of an escalating gluten consumption to activate Coeliac Disease (CeD) in (a) a small cohort of people with diet-managed CeD treated with a placebo (n=10), and in (b) cohorts following low (L3-10; n=40) and medium (L3-20; n=10) dose hookworm inocula.
The investigators 4 aims for the study are:
Aim 1: Undertake a multiple-phase and escalating gluten challenge assessing safety to gluten exposure in hookworm-naïve and hookworm-infected people with CeD.
Aim 2: This phase Ib study recognizes that the evidence supporting this novel intervention is rudimentary and addresses amongst others the following questions: (a) The importance of L3 dose on Participant health, and (b) the importance of L3 dose on the safety of escalating gluten challenge and (c) the need for a comparator group should a phase II trial be warranted.
Aim 3: Examine the changes in intestinal T cell responses induced by hookworm infection and gluten exposure.
Aim 4: Assess the impact of hookworm infection and purified hookworm-derived proteins on gluten peptide-specific immune responses ex vivo.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has provided written informed consent and is willing to comply with all Protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures and in the opinion of the Investigator has a good understanding of the Protocol, the length of the study and the demands of the study.
✓. Aged between 18-80 (at time of consent);
✓. Have a pre-treatment histological diagnosis of Marsh grade 3 CeD;
✓. Have a pre-trial V:C \>2.0;
✓. Have elevated tTG or endomysial Ab +ve pre-trial;
✓. Have been adherent to a gluten-free diet for \>6 months pre-enrolment;
✓. Have a tTG \<20 IU/mL (normal \<15) at screening;
✓. Have a CSI \<35 at screening;
Exclusion criteria
✕. Have any finding at screening that in the opinion of the Investigator or medical monitor would compromise the safety of the Participant or affect their ability to adhere to protocol scheduled visits, treatment plan, laboratory tests, and other trial procedures.
What they're measuring
1
Safety of 30-week gluten challenge
Timeframe: 44 weeks
Trial details
NCT IDNCT02754609
SponsorJames Cook University, Queensland, Australia
✕. Have participated in any other clinical trial and/or have received an investigational drug or device within 30 days of screening.
✕. Have history or current evidence of any of the following: compromised respiratory function (chronic obstructive pulmonary disease, respiratory depression, signs or symptoms of hypoxia at screening); thyroid pathology (unless stabilized and euthyroid for \>3 months at the time of screening); hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; evidence of clinically significant chronic cardiac, hepatic or renal disease; psychiatric illness (poorly controlled); seizure disorder or any other chronic health issues that in the opinion of the Investigator would exclude the Participant from the trial.
✕. History of substance abuse or current substance abuse that in the opinion of the Investigator would exclude the Participant from the trial.
✕. Have a history of intolerance, allergy or hypersensitivity to the proposed placebo - Tabasco® Sauce or any of its known ingredients.
✕. Have a history of intolerance, allergy or hypersensitivity to the proposed anthelmintic - mebendazole.
✕. Have a history of intolerance, allergy or hypersensitivity to the proposed chemicals used in preparation of N.americanus - amphotericin B and Betadine that in the opinion of the Investigator would exclude the Participant from the trial.
✕. Current requirement for consistent use of anti-inflammatory drugs (includes prescription and over the counter medication \>2 doses per week, that in the opinion of the Investigator would significantly alter the Participant's immunity), aspirin exceeding 125 mg/day or the use of immunotherapeutics;