Trials / Completed
CompletedNCT03565939
Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- ParaTech A/S · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative, exploratory phase II proof of concept trial. The trial will be conducted with 2 treatment groups as a parallel group comparison and will serve to compare a 7500 TSO regimen vs. placebo for achieving clinically meaningful responses in Ulcerative Colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Trichuris suis ova | Eggs from the pig whipworm |
| BIOLOGICAL | Placebo | Solution without TSO |
Timeline
- Start date
- 2018-05-04
- Primary completion
- 2022-01-10
- Completion
- 2022-01-10
- First posted
- 2018-06-21
- Last updated
- 2022-04-22
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03565939. Inclusion in this directory is not an endorsement.