Desensitising Celiac Disease Patients With the Human Hookworm

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Celiac Disease
Interventions
BIOLOGICAL

Necator americanus

Previously inoculated subjects will be further inoculated as previously undertaken with 20 3rd stage infective Na larvae (10 + 10 over 4 weeks). Four weeks after the 2nd inoculation, each participant will receive a micro-dose of gluten (10 mg daily) as pasta for 8 weeks, to be followed by a low-dose of gluten (50 mg daily) for 8 weeks. After this, a detailed assessment involving upper endoscopy and duodenal biopsy will be performed before deciding on an individual case basis that it is safe for the participant to proceed to challenge. A gluten challenge of 1 G (15-20 G of pasta or a ½ slice of standard white bread) twice weekly for 12 weeks will commence.

BIOLOGICAL

Necator americanus

After completion of the previously planned challenge, volunteers will be invited to extend the gluten challenge. The extension is for 4 weeks total. The gluten challenge is stepwise: gluten 10 mg daily for one week, 50 mg daily for one week and finally 3 grams daily for 2 weeks. The outcome measure is serum tissue transglutaminase to be compared before and after the intervention.

Trial Locations (1)

4032

Prince Charles Hospital, Chermside

All Listed Sponsors
collaborator

National Health and Medical Research Council, Australia

OTHER

lead

The Prince Charles Hospital

OTHER_GOV

NCT01661933 - Desensitising Celiac Disease Patients With the Human Hookworm | Biotech Hunter | Biotech Hunter