Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
Public ClinicalTrials.gov record NCT01576471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active Crohn's disease. This study will also have an optional open-label extension for patients completing the double-blind phase of the study.
Study identification
- NCT ID
- NCT01576471
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2012 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Jun 29, 2017
2012 – 2014
United States locations
- U.S. sites
- 73
- U.S. states
- 30
- U.S. cities
- 67
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | — |
| Lynn Institue of the Ozarks | Little Rock | Arkansas | 72205 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Rokay Kamyar, MD Inc | La Mesa | California | 91941 | — |
| Medvin Clinical Research | La Mirada | California | 90638 | — |
| Lakewood Primary Care Medical Group, Inc | Lakewood | California | 90712 | — |
| Alliance Research | Long Beach | California | 90804 | — |
| Collaborative Neuroscience Network, Inc. | Long Beach | California | 90806 | — |
| Alliance Clinical Research, LLC | Oceanside | California | 92056 | — |
| Digestive Care Associates | San Carlos | California | 94070 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| Gastroenterology of the Rockies | Lafayette | Colorado | 80026 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Sanitas Research | Coral Gables | Florida | 33134 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | — |
| The Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32204 | — |
| Gastroenterology Associates of Osceola | Kissimmee | Florida | 34741 | — |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | — |
| Paramount Public Health & Research Management Services | Miami | Florida | 33135 | — |
| Community Research Foundation, Inc | Miami | Florida | 33155 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 336003 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Selah Medical Center | Boise | Idaho | 83704 | — |
| Northwest Gastroenterologists | Arlington Heights | Illinois | 60005 | — |
| Suburban Clinical Research | Bolingbrook | Illinois | 60490 | — |
| Suburban Clinical Research | Burr Ridge | Illinois | 60527 | — |
| The University of Chicago Hospital | Chicago | Illinois | 60637 | — |
| Medisphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Cotton O'Neil Digestive Healthcare | Topeka | Kansas | 66606 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health Services | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Beyer Research | Kalamazoo | Michigan | 49009 | — |
| Midwest Center for Clinical Research | Lee's Summit | Missouri | 64064 | — |
| Center for Digestive and Liver Disease | Mexico | Missouri | 65265 | — |
| Billings Clinic Research Center | Billings | Montana | 59101 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Reno Clinical Trials | Sparks | Nevada | 89434 | — |
| South Jersey Medical Associates, P.A. | Blackwood | New Jersey | 08012 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Digestive Health Physicians | Cheektowaga | New York | 14225 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Metropolitan Research Associates | New York | New York | 10016 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | — |
| Consultants for Clinical Research, Inc | Cincinnati | Ohio | 45219 | — |
| The Ohio State University-Inflammatory Bowel Disease Ctr | Columbus | Ohio | 43210 | — |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | — |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | — |
| Northwest Gastroenterology Clinic, LLD | Portland | Oregon | 97210 | — |
| James J. Boylan Gastroenterology and Liver Diseases | Bethlehem | Pennsylvania | 18015 | — |
| Shirish A. Amin, MD, PC | Indiana | Pennsylvania | 15701 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Donald Guthrie Foundation for Education & Research | Sayre | Pennsylvania | 18840 | — |
| Cherry Tree Medical | Uniontown | Pennsylvania | 15401 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Austin Gastroenterology PA/Professional Quality Research, Inc | Austin | Texas | 78705 | — |
| Lovelace Scientific Resources, Inc. | Austin | Texas | 78758 | — |
| Diagnostic Clinic of Houston | Houston | Texas | 77004 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01576471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2017 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01576471 live on ClinicalTrials.gov.