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

NCT03565939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2022-04-22

No results posted yet for this study

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

  • Ulcerative Colitis Chronic Moderate

Interventions

BIOLOGICAL

Trichuris suis ova

Eggs from the pig whipworm

BIOLOGICAL

Placebo

Solution without TSO

Sponsors & Collaborators

  • ParaTech A/S

    lead INDUSTRY

Principal Investigators

  • Andreas M Petersen, MD, Ph.D · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565939 on ClinicalTrials.gov