Hookworm Therapy for Coeliac Disease (NainCeD-3)
Celiac Disease
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease, Necator americanus, Helminths, Autoimmunity, Clinical Trials, Phase I, Randomized Controlled Trial
Eligibility Criteria
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;
If female, has met either of criterion "a or b" below:
- If of non-childbearing potential, has met 1 of the following - Amenorrheic for at least 2 years, or has had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening, or has had a tubal ligation at least 8 weeks prior to screening.
- If of childbearing potential, must be willing to use the acceptable methods of contraception and abide by the timelines as indicated
- In the opinion of the Investigator is in good general health
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.
- 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;
- Diagnosis of cancer which has been in remission for < 5 years, excluding Participants with adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Poor venous access making the Participant unable to comply with the safety laboratory testing and/or endoscopy sedation requirements.
- Are an employee of the Sponsor, Investigator or study centre or immediate family of such employees or the Investigator.
Sites / Locations
- Prince Charles Hospital
- Logan Hospital
- Townsville Hospital
- Christchurch Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Necator americanus-hookworm larvae L3-10
Tabasco® Sauce
Necator americanus-hookworm larvae L3-20
A total of 40 participants week 0 and week 8 will have low dose hookworms present in 2-3 drops of water applied to their skin and then covered in a light dressing. The hookworms are Necator americanus-hookworm larvae L3; 10 L3 in 200 microliter (uL) of deionized water presented in an Eppendorf tube. All participants will undergo interventions of Gluten free diet, Gluten micro-challenge, Inadvertent gluten challenge and Moderate gluten challenge. At week 42, participants will have the option of going on the liberal diet.
A total of 10 participants at week 0 and week 8 will have Tabasco® Sauce present in 2-3 drops of water applied to their skin and covered in a light dressing. Tabasco® Sauce is an ideal placebo as the sensation to the skin is similar to a hookworm. All participants will undergo interventions of Gluten free diet, Gluten micro-challenge, Inadvertent gluten challenge and Moderate gluten challenge.
A total of 10 participants at week 0 and week 8 will have medium dose hookworms present in 2-3 drops of water applied to their skin and then covered in a light dressing. The hookworms are Necator americanus-hookworm larvae L3; 20 L3 in 200 uL of deionized water presented in an Eppendorf tube. All participants will undergo interventions of Gluten free diet, Gluten micro-challenge, Inadvertent gluten challenge and Moderate gluten challenge. At week 42, participants will have the option of going on the liberal diet.