Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease (TRUST-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279577
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

January 18, 2011
January 19, 2011
February 10, 2015
November 2010
February 2014   (Final data collection date for primary outcome measure)
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01279577 on Archive Site
  • Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
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

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn´s Disease
  • Drug: Low dose TSO
    Low dose TSO suspension
  • Drug: Medium dose TSO
    Medium dose TSO suspension
  • Drug: High dose TSO
    High dose TSO suspension
  • Drug: Placebo
    Placebo solution
  • Experimental: Low dose TSO
    Low dose suspension of TSO
    Intervention: Drug: Low dose TSO
  • Experimental: Medium dose TSO
    Medium dose suspension of TSO
    Intervention: Drug: Medium dose TSO
  • Experimental: High dose TSO
    High dose suspension of TSO
    Intervention: Drug: High dose TSO
  • Placebo Comparator: Placebo
    Placebo solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2006-000720-13 ( EudraCT Number )
Not Provided
Not Provided
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Jürgen Schölmerich, Prof. Klinikum der Johann Wolfgang Goethe-Universität
Dr. Falk Pharma GmbH
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP