Phase 2
Completed N=12
Desensitising Celiac Disease Patients With the Human Hookworm
Source: ClinicalTrials.gov NCT01661933 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Duodenal Villus Height:Crypt Depth — 2.73; 2.73 Ratio — p=0.693
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.
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 |
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. Informational only — not medical advice.