Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease

Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01279577

Acronym

TRUST-2

Enrollment

254

Registered

2011-01-19

Start date

2010-11-30

Completion date

2014-02-28

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn´s Disease

Keywords

Crohn´s disease, Trichuris suis, randomized, placebo, induction of remission, porcine whipworm

Brief summary

This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.

Interventions

DRUGLow dose TSO

Low dose TSO suspension

DRUGMedium dose TSO

Medium dose TSO suspension

DRUGHigh dose TSO

High dose TSO suspension

DRUGPlacebo

Placebo solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Major Inclusion Criteria: * Signed informed consent, * Man or woman between 18 and 75 years of age, * Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria, * Negative pregnancy test in females of childbearing potential. Major

Exclusion criteria

* Bowel surgery within the last 3 months prior to baseline, * Resection of more than 50 cm of the ileum, * Ileostomy or colostomy, * Septic complications, * Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture), * Abscess, perforation, fistulas, or perianal lesions, * Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus), * Clinical signs of stricturing disease, * Parenteral or tube feeding, * Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\] at screening), liver cirrhosis, or portal hypertension, * Abnormal renal function (Cystatin C \> ULN) at screening, * Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results, * Any condition associated with significant immunosuppression, * Active malignancy or treatment with anticancer drugs during the last 5 years. * Existing or intended pregnancy or breast-feeding, * Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

Design outcomes

Primary

Measure	Time frame
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150	12 weeks

Secondary

Measure	Time frame
Reduction of > 100 points in CDAI	12 weeks
Adverse events	12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026