ClinicalTrials.gov record
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
ClinicalTrials.gov ID: NCT01652157
Public ClinicalTrials.gov record NCT01652157. 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 Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.
Study identification
- NCT ID
- NCT01652157
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 17 participants
Conditions and interventions
Conditions
Interventions
- ULTRESA Biological
- PANCREAZE Biological
- CREON Biological
- ZENPEP Biological
- other non-sponsor pancreatic enzyme replacement therapy Biological
- PERTZYE Biological
- No pancreatic enzyme replacement therapy Other
Biological · Other
Eligibility (public fields only)
- Age range
- 0 Months to 99 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 31, 2012 (Actual)
- Primary completion
- Apr 8, 2020 (Actual)
- Completion
- Apr 8, 2020 (Actual)
- Last update posted
- Mar 22, 2021
2012 – 2020
United States locations
- U.S. sites
- 123
- U.S. states
- 46
- U.S. cities
- 105
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama /ID# 78920 | Birmingham | Alabama | 35233 | — |
| Alaska Medical Center /ID# 79256 | Anchorage | Alaska | 99508 | — |
| Phoenix Children's Hospital /ID# 78906 | Phoenix | Arizona | 85016-7710 | — |
| University of Arizona Cancer Center - North Campus /ID# 78939 | Tucson | Arizona | 85719-1478 | — |
| Arkansas Children's Hospital /ID# 79265 | Little Rock | Arkansas | 72202 | — |
| University of Arkansas for Medical Sciences /ID# 76785 | Little Rock | Arkansas | 72205 | — |
| Ucsd /Id# 105039 | La Jolla | California | 92093 | — |
| Loma Linda University /ID# 79237 | Loma Linda | California | 92354 | — |
| Miller Childrens Hospital /ID# 78896 | Long Beach | California | 90806 | — |
| Kaiser Permanente Regional Met /ID# 79235 | Los Angeles | California | 90027 | — |
| Usc /Id# 76793 | Los Angeles | California | 90033 | — |
| Children's Hosp and Res Ctr /ID# 79295 | Oakland | California | 94609 | — |
| Kaiser Permanente /ID# 78899 | Oakland | California | 94611 | — |
| UC Davis Comprehensive Cancer Center - Main /ID# 118935 | Sacramento | California | 95817 | — |
| California Pacific Medical Ctr /ID# 76775 | San Francisco | California | 94115 | — |
| Univ California, San Francisco /ID# 78925 | San Francisco | California | 94143-2204 | — |
| Stanford University /ID# 95156 | Stanford | California | 94305 | — |
| Univ of Colorado Cancer Center /ID# 79277 | Aurora | Colorado | 80045 | — |
| National Jewish Health /ID# 76784 | Denver | Colorado | 80206 | — |
| CT Childrens Medical Ctr, US /ID# 78923 | Hartford | Connecticut | 06106 | — |
| Yale University /ID# 78940 | New Haven | Connecticut | 06510 | — |
| Nemours/Alfred duPont Hospital for Children /ID# 78945 | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center /ID# 79373 | Washington D.C. | District of Columbia | 20010 | — |
| Central FL Pulmonary Altamonte /ID# 76776 | Altamonte Springs | Florida | 32701 | — |
| University of Florida - Archer /ID# 76790 | Gainesville | Florida | 32610 | — |
| University of Florida - Archer /ID# 78928 | Gainesville | Florida | 32610 | — |
| Joe DiMaggio Children's Hospital at Memorial /ID# 79234 | Hollywood | Florida | 33021-5402 | — |
| Nemour Child Clin FL, US /ID# 78898 | Jacksonville | Florida | 32207 | — |
| University of Miami, Miller School of Medicine /ID# 78927 | Miami | Florida | 33136 | — |
| Nemours Children's Clinic /ID# 78917 | Orlando | Florida | 32801 | — |
| Arnold Palmer Hosp Children /ID# 96075 | Orlando | Florida | 32806 | — |
| All Children's Hospital /ID# 79264 | St. Petersburg | Florida | 33701 | — |
| Emory University Hospital /ID# 79394 | Atlanta | Georgia | 30322 | — |
| Children's Healthcare of Atlanta - Ferry Rd /ID# 116275 | Atlanta | Georgia | 30342-1605 | — |
| Georgia Regents University /ID# 79395 | Augusta | Georgia | 30912 | — |
| St Luke's Cystic Fibrosis Center of Idaho /ID# 79259 | Boise | Idaho | 83702 | — |
| Duplicate_Childrens Hospital of Chicago /ID# 79296 | Chicago | Illinois | 60611 | — |
| University of Chicago /ID# 78924 | Chicago | Illinois | 60637-1443 | — |
| Loyola University Medical Ctr /ID# 76780 | Maywood | Illinois | 60153 | — |
| Advocate Lutheran Gen Children /ID# 76781 | Park Ridge | Illinois | 60068 | — |
| OSF Saint Francis Medical Ctr /ID# 78905 | Peoria | Illinois | 61603 | — |
| Lutheran Hospital of Indiana /ID# 79238 | Fort Wayne | Indiana | 46804 | — |
| Indiana University /ID# 121395 | Indianapolis | Indiana | 46202 | — |
| Indiana University /ID# 78903 | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics /ID# 78921 | Iowa City | Iowa | 52242 | — |
| University of Kansas Health Sy /ID# 78929 | Kansas City | Kansas | 66160-8500 | — |
| Via Christi Specialty Clinics /ID# 78946 | Wichita | Kansas | 67214 | — |
| Kentucky Clinic /ID# 78922 | Lexington | Kentucky | 40506 | — |
| University of Louisville /ID# 78926 | Louisville | Kentucky | 40202 | — |
| Tulane Univ /ID# 78916 | New Orleans | Louisiana | 70112 | — |
| Louisiana State Univ HSC /ID# 78943 | Shreveport | Louisiana | 71130 | — |
| MMP Women's Health /ID# 78894 | Portland | Maine | 04102 | — |
| Johns Hopkins University /ID# 78893 | Baltimore | Maryland | 21287 | — |
| Tufts-New England Medical Ctr /ID# 79254 | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital /ID# 78895 | Boston | Massachusetts | 02114 | — |
| Boston Childrens Hospital /ID# 79276 | Boston | Massachusetts | 02115 | — |
| Baystate Medical Center /ID# 103437 | Springfield | Massachusetts | 01199 | — |
| UMass Memorial Medical Center /ID# 78954 | Worcester | Massachusetts | 01655 | — |
| University of Michigan Hospitals /ID# 99035 | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital of MI /ID# 79278 | Detroit | Michigan | 48201 | — |
| Michigan State University /ID# 78950 | East Lansing | Michigan | 48824 | — |
| Helen DeVos Childrens Hospital /ID# 79397 | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota /ID# 76791 | Minneapolis | Minnesota | 55455-0356 | — |
| Univ of Mississippi Med Ctr,US /ID# 78934 | Jackson | Mississippi | 39216-4643 | — |
| University of Missouri /ID# 109755 | Columbia | Missouri | 65212 | — |
| The Children's Mercy Hospital /ID# 78948 | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Ho /ID# 79275 | St Louis | Missouri | 63104 | — |
| Children's Hospital St Louis /ID# 78910 | St Louis | Missouri | 63110 | — |
| Univ Nebraska Med Ctr /ID# 78932 | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center /ID# 78957 | Lebanon | New Hampshire | 03756 | — |
| St. Barnabas Medical Center /ID# 79258 | Livingston | New Jersey | 07039 | — |
| Monmouth Medical Center /ID# 78901 | Long Branch | New Jersey | 07740 | — |
| Goryeb Chidlren's Hospital /ID# 76782 | Morristown | New Jersey | 07960 | — |
| Rutgers Robert Wood Johnson /ID# 119978 | New Brunswick | New Jersey | 08901 | — |
| Albany Medical College /ID# 76774 | Albany | New York | 12208 | — |
| Cystic Fibrosis Therapeutics /ID# 78941 | Buffalo | New York | 14222 | — |
| North Shore University Hospital /ID# 76779 | New Hyde Park | New York | 11040 | — |
| Mount Sinai Beth Israel /ID# 76773 | New York | New York | 10003 | — |
| Columbia Univ Medical Center /ID# 79376 | New York | New York | 10032-3725 | — |
| Univ Rochester Med Ctr /ID# 92713 | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University - Downtown /ID# 78912 | Syracuse | New York | 13210 | — |
| New York Medical College /ID# 78956 | Valhalla | New York | 10595 | — |
| Univ NC Chapel Hill /ID# 78937 | Chapel Hill | North Carolina | 27514-4220 | — |
| Duke University Medical Center /ID# 79393 | Durham | North Carolina | 27710-3000 | — |
| Mid Dakota Clinic, PC /ID# 78958 | Bismarck | North Dakota | 58504 | — |
| Akron Childrens Hospital /ID# 79263 | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital /ID# 79375 | Cincinnati | Ohio | 45229 | — |
| University of Cincinnati /ID# 76789 | Cincinnati | Ohio | 45267-0585 | — |
| Case Western Reserve Univ /ID# 78904 | Cleveland | Ohio | 44106 | — |
| Nationwide Childrens Hospital /ID# 78897 | Columbus | Ohio | 43205 | — |
| The Childrens Medical Center /ID# 78915 | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital /ID# 78913 | Toledo | Ohio | 43606 | — |
| Univ Oklahoma HSC /ID# 79279 | Oklahoma City | Oklahoma | 73104 | — |
| Kaiser Permanente, NW /ID# 79236 | Portland | Oregon | 97227 | — |
| Oregon Health and Science University /ID# 78900 | Portland | Oregon | 97239 | — |
| Geisinger Medical Center /ID# 79233 | Danville | Pennsylvania | 17822 | — |
| Penn State Child Hosp.Hersh,PA /ID# 79398 | Hershey | Pennsylvania | 17033 | — |
| Children's Hosp Philadelphia /ID# 79280 | Philadelphia | Pennsylvania | 19104 | — |
| Drexel Univ College of Med /ID# 76777 | Philadelphia | Pennsylvania | 19129 | — |
| St. Christopher's Hospital /ID# 78908 | Philadelphia | Pennsylvania | 19134 | — |
| Child Hosp of Pittsburgh,PA /ID# 79281 | Pittsburgh | Pennsylvania | 15213-2583 | — |
| Rhode Island Hospital /ID# 79274 | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina /ID# 79262 | Charleston | South Carolina | 29425 | — |
| Sanford Research/USD /ID# 78909 | Sioux Falls | South Dakota | 57104-8805 | — |
| LeBonheur Children's Med Ctr /ID# 78938 | Memphis | Tennessee | 38103 | — |
| Vanderbilt Univ Med Ctr /ID# 78947 | Nashville | Tennessee | 37232-0011 | — |
| Specially for Children /ID# 79213 | Austin | Texas | 78723 | — |
| UT Southwestern Medical Center /ID# 78914 | Dallas | Texas | 75390-7208 | — |
| Cook Children's Med. Center /ID# 78949 | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine /ID# 79273 | Houston | Texas | 77030-3411 | — |
| Univ Texas HSC San Antonio /ID# 79374 | San Antonio | Texas | 78229 | — |
| The Univ Texas HSC at Tyler /ID# 79261 | Tyler | Texas | 75708 | — |
| University of Utah /ID# 76794 | Salt Lake City | Utah | 84112-5500 | — |
| University of Vermont Medical Center /ID# 78933 | Burlington | Vermont | 05401-1473 | — |
| University of Virginia /ID# 78942 | Charlottesville | Virginia | 22908 | — |
| Child Hosp of the King's Dtr's /ID# 79293 | Norfolk | Virginia | 23507 | — |
| Children's Hospital of Richmon /ID# 78955 | Richmond | Virginia | 23298 | — |
| Seattle Children's Hospital /ID# 78902 | Seattle | Washington | 98105 | — |
| Arthritis Northwest, PLLC /ID# 79257 | Spokane | Washington | 99204-2336 | — |
| West Virginia Univ School Med /ID# 78953 | Morgantown | West Virginia | 26506 | — |
| Univ of Wisconsin Hosp/Clinics /ID# 78944 | Madison | Wisconsin | 53792-0001 | — |
| Froedtert & the Medical College of Wisconsin /ID# 76778 | Milwaukee | Wisconsin | 53226-3522 | — |
| Children's Hospital Wisconsin - Milwaukee Campus /ID# 79294 | Milwaukee | Wisconsin | 53226 | — |
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 NCT01652157, 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 Mar 22, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01652157 live on ClinicalTrials.gov.