Hookworm Therapy for Coeliac Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

Conditions
Celiac Disease
Interventions
OTHER

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.

OTHER

Inadvertent gluten challenge

From week 24 to week 36, all participants will be on gluten 50mg/day and 1g twice weekly.

OTHER

Moderate gluten challenge

From week 36 to week 42, all participants will be on gluten 2g/day.

OTHER

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.

OTHER

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.

OTHER

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

OTHER

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.

OTHER

Gluten free diet

From week 0 to week 12, all participants will be on a gluten free diet.

Trial Locations (4)

4032

Prince Charles Hospital, Brisbane

4131

Logan Hospital, Logan City

4710

Christchurch Hospital, Christchurch

4812

Townsville Hospital, Townsville

All Listed Sponsors
collaborator

Townsville Hospital

OTHER_GOV

collaborator

The Prince Charles Hospital

OTHER_GOV

collaborator

Christchurch Hospital

OTHER

collaborator

Logan Hospital, Queensland

OTHER_GOV

collaborator

Australian Institute of Tropical Health and Medicine

OTHER

collaborator

QIMR Berghofer Medical Research Institute

OTHER

collaborator

National Health and Medical Research Council, Australia

OTHER

lead

James Cook University, Queensland, Australia

OTHER