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Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

This study has been terminated.
(MFR's business decision to d/c TSO production -unrelated to any safety concern.)
Sponsor:
Collaborators:
Coronado Biosciences, Inc.
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01953354
First received: September 24, 2013
Last updated: February 9, 2017
Last verified: February 2017
Results First Received: December 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Colitis, Ulcerative
Interventions: Biological: Trichuris suis ova (TSO)
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of all the participating sites, nine reached the study intervention randomization phase for >=one participant.The first site was activated in November 2013 and the last participant was randomized in March 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TSO 7500 Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
Placebo Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.

Participant Flow:   Overall Study
    TSO 7500   Placebo
STARTED   9   7 
COMPLETED   8   5 
NOT COMPLETED   1   2 
Withdrawal by Subject                0                1 
Decision of Sponsor                0                1 
Disease Exacerbation                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Randomized population included all subjects who were randomized to receive either TSO 7500 or placebo.

Reporting Groups
  Description
TSO 7500 Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
Placebo Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
Total Total of all reporting groups

Baseline Measures
   TSO 7500   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   7   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.0  (9.0)   44.7  (11.4)   42.1  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  44.4%      2  28.6%      6  37.5% 
Male      5  55.6%      5  71.4%      10  62.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1  11.1%      1  14.3%      2  12.5% 
Not Hispanic or Latino      8  88.9%      6  85.7%      14  87.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2  22.2%      0   0.0%      2  12.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      7  77.8%      7 100.0%      14  87.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   9   7   16 
Percentage of Participants at Baseline Who Were Taking a Corticosteroid [1] 
[Units: Percentage of participants]
 33.3   14.3   25.0 
[1] Percentage of participants at Baseline who were taking a corticosteroid prescribed by a physician.
Percentage of Participants at Baseline Who Were Taking Thiopurine [1] 
[Units: Percentage of participants]
 11.1   0.0   6.3 
[1] Percentage of participants at Baseline who were taking Thiopurine prescribed by a physician.
Mayo Score for Assessment of Ulcerative Colitis Activity [1] 
[Units: Total Mayo Score]
Mean (Standard Deviation)
 9.0  (1.2)   7.4  (1.3)   8.3  (1.5) 
[1] The Mayo Score assesses four areas of ulcerative colitis activity: stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment. The physician rates each of the four areas on a scale of 0 to 3, with a total possible score of 12. A higher score indicates more disease activity.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved a Clinical Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percent of Participants Who Achieved Remission at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Percent of Participants With Healed Colonic Mucosa at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Percent of Participants With a Modified Clinical Response   [ Time Frame: From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks ]

5.  Secondary:   Time to Modified Clinical Response   [ Time Frame: From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed. ]

6.  Secondary:   Percent of Participants With Colonoscopic Evidence of Visible Worm   [ Time Frame: From Day 0 through end of follow-up, up to 36 weeks ]

7.  Secondary:   Percent of Participants With Increase in Diarrhea   [ Time Frame: From Day 0 through end of follow-up, up to 36 weeks ]

8.  Secondary:   Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added   [ Time Frame: From Day 0 through Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Recruitment was slower than anticipated. The study was ultimately terminated when the manufacturer decided to discontinue study product production.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01953354     History of Changes
Other Study ID Numbers: DAIT AUC02
Study First Received: September 24, 2013
Results First Received: December 16, 2016
Last Updated: February 9, 2017