drugset / Trial / NCT03565939

Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)

NCT03565939 ↗

Phase 2 Completed 119 enrolled ParaTech A/S
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-05-04
Primary completion
2022-01-10
Completion
2022-01-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trichuris suis ova Other / unclassified 7500 unknown Oral

Indications