Phase 2
N=12
Desensitising Celiac Disease Patients With the Human Hookworm
Celiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT01661933 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Duodenal Villus Height:Crypt Depth — 2.73; 2.73 Ratio — p=0.693
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Necator americanus (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Prince Charles Hospital
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duodenal Villus Height:Crypt Depth |
2.73; 2.73 | 0.693 |
| SECONDARY Intraepithelial Lymphocyte Count |
33.40; 35.00 | =0.837 |
| SECONDARY Number of Participants With 2 Points Increase in Marsh Score Post GC-1g |
1 | =0.99 |
| SECONDARY Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL) |
4.12; 2.99; 2.11 | =0.005 sig |
Summary
We have established that the hookworm Necator americanus (Na) dramatically alters the local and systemic immune landscape of the infected human host. Consistent with the principle of desensitisation, diet managed celiac disease subjects previously infected by us with Na will be invited to receive small incremental doses of gluten as pasta (3-25 mm straw of spaghetti) over 16 weeks. Each participant will then be carefully re-assessed to determine if it is appropriate to undertake a 12-week gluten challenge.
Eligibility Criteria
Inclusion Criteria
- Previously enrolled adults who received an experimental hookworm infection with diet treated celiac disease.
Exclusion Criteria
- Immune suppressive therapies
Data sourced from ClinicalTrials.gov (NCT01661933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.