54
Participants
Start Date
September 30, 2016
Primary Completion Date
October 31, 2019
Study Completion Date
October 31, 2019
Gluten micro-challenge
From week 12 to week 24, all participants will start a gluten micro-challenge from 10mg/day for the first 2 weeks escalating over the this period to 50mg/day at the end of week 24.
Inadvertent gluten challenge
From week 24 to week 36, all participants will be on gluten 50mg/day and 1g twice weekly.
Moderate gluten challenge
From week 36 to week 42, all participants will be on gluten 2g/day.
Liberal diet
From week 42, all participants will be unblinded and those who have received hookworm therapy have the option to go on a liberal diet of more than 10g of gluten/day from week 42 to week 94.
Necator americanus-hookworm larvae L3-10
A total of 40 participants at week 0 and week 8 will have hookworms L3-10 present in 2-3 drops of water applied to their skin and then covered in a light dressing.
Tabasco® Sauce
Arm: Placebo Comparator: Tabasco® Sauce 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
Necator americanus-hookworm larvae L3-20
A total of 40 participants at week 0 and week 8 will have hookworms L3-20 present in 2-3 drops of water applied to their skin and then covered in a light dressing.
Gluten free diet
From week 0 to week 12, all participants will be on a gluten free diet.
Prince Charles Hospital, Brisbane
Logan Hospital, Logan City
Christchurch Hospital, Christchurch
Townsville Hospital, Townsville
Townsville Hospital
OTHER_GOV
The Prince Charles Hospital
OTHER_GOV
Christchurch Hospital
OTHER
Logan Hospital, Queensland
OTHER_GOV
Australian Institute of Tropical Health and Medicine
OTHER
QIMR Berghofer Medical Research Institute
OTHER
National Health and Medical Research Council, Australia
OTHER
James Cook University, Queensland, Australia
OTHER