Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova (MUCUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01433471
First received: September 6, 2011
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: April 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Ulcerative Colitis
Intervention: Drug: Trichuris suis ova

  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
No text entered.

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
Trichuris Suis Ova Followed by Placebo

Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover

Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks

Placebo Followed by Trichuris Suis Ova

Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover

Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks


Participant Flow:   Overall Study
    Trichuris Suis Ova Followed by Placebo     Placebo Followed by Trichuris Suis Ova  
STARTED     2     2  
COMPLETED     2     1  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Trichuris Suis Ova Followed by Placebo

Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover

Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks

Placebo Followed by Trichuris Suis Ova

Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover

Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks

Total Total of all reporting groups

Baseline Measures
    Trichuris Suis Ova Followed by Placebo     Placebo Followed by Trichuris Suis Ova     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     2     4  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     1     1     2  



  Outcome Measures
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1.  Primary:   Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

2.  Primary:   Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

3.  Primary:   Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

4.  Primary:   Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

5.  Secondary:   Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

6.  Secondary:   Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks   [ Time Frame: Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks ]


  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
Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned.


  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: Martin Wolff
Organization: NYU Langone Medical Center
phone: (646) 329-7259
e-mail: martin.wolff@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01433471     History of Changes
Other Study ID Numbers: R#11-02470
Study First Received: September 6, 2011
Results First Received: April 26, 2016
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board