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| Name | Class |
|---|---|
| OpenBiome | INDUSTRY |
| University of California, San Diego | OTHER |
| University of Pennsylvania | OTHER |
| University of Minnesota |
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A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness
This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None - Observational | Other | None - Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment related Adverse Events | Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases. | over 10 Years |
| Disease Re-occurrence Following FMT | Assess effectiveness of FMT by monitoring disease re-occurrence post treatment. | over 10 Years |
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Inclusion Criteria:
Recipient Inclusion Criteria
Donor Inclusion
Exclusion Criteria:
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All patients receiving FMT or other gut-related-microbiota products and the donors providing specimens for the enrolled patients' FMT. Patients will be enrolled regardless of race, gender, ethnicity, or age.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonya Serra, MSc | Contact | 3019412616 | sserra@gastro.org | |
| Lydia Fredell, MA | Contact | 3019419797 | lfredell@gastro.org |
| Name | Affiliation | Role |
|---|---|---|
| Gary D Wu, MD | Co-Director, PennCHOP Microbiome Program | Principal Investigator |
| Colleen Kelly, MD | Brigham and Women's Hospital | Principal Investigator |
| Loren Laine, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Withdrawn | Phoenix | Arizona | 85016 | United States | |
| Children's Hospital of Los Angeles |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2017 | Oct 17, 2017 |
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| OTHER |
| Loyola University Chicago | OTHER |
| Commure, Inc | UNKNOWN |
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| Yale University |
| Principal Investigator |
| Active, not recruiting |
| Los Angeles |
| California |
| 90027 |
| United States |
| University of California | Withdrawn | Los Angeles | California | 90095 | United States |
| Stanford University | Recruiting | Redwood City | California | 94063 | United States |
|
| Sutter Roseville Medical Center | Recruiting | Roseville | California | 95661 | United States |
|
| University of California San Francisco | Recruiting | San Francisco | California | 94115 | United States |
|
| Ventura Clinical Trials | Withdrawn | Ventura | California | 93003 | United States |
| Yale New Haven Hospital | Recruiting | Hamden | Connecticut | 06518 | United States |
|
| MedStar Georgetown University Hospital | Active, not recruiting | Georgetown | District of Columbia | 20007 | United States |
| Best Quality Research, Inc. | Withdrawn | Hialeah | Florida | 33016 | United States |
| University of Miami, Miller School of Medicine | Recruiting | Miami | Florida | 33136 | United States |
|
| GI Pros | Withdrawn | Naples | Florida | 34102 | United States |
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30307 | United States |
|
| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Chicago School of Medicine | Active, not recruiting | Chicago | Illinois | 60637 | United States |
| NorthShore University Health System | Terminated | Evanston | Illinois | 60201 | United States |
| Loyola University Medical Center | Active, not recruiting | Maywood | Illinois | 60153 | United States |
| Loyola University of Chicago/ Loyola University Medical Center | Recruiting | Maywood | Illinois | 60153 | United States |
|
| Carle Foundation Hospital | Completed | Urbana | Illinois | 61801 | United States |
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Kansas Medical Center Research Institute | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| Ochsner | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| Johns Hopkins University School of Medicine | Completed | Baltimore | Maryland | 21287 | United States |
| American Gastroenterological Association | Active, not recruiting | Bethesda | Maryland | 20814 | United States |
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| UMass Memorial Health | Recruiting | Worcester | Massachusetts | 01604 | United States |
|
| St. Joseph Mercy Hospital | Completed | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Henry Ford Health Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Mayo Clinic - Division of Pediatric Gastroenterology | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Valley Hospital and Medical Center | Active, not recruiting | Las Vegas | Nevada | 89146 | United States |
| Atlantic Health System | Completed | Morristown | New Jersey | 07960 | United States |
| Rutgers | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| Penn Medicine Princeton Health | Not yet recruiting | Plainsboro | New Jersey | 08536 | United States |
|
| Concorde Medical Group | Withdrawn | New York | New York | 10016 | United States |
| New York University School of Medicine | Recruiting | New York | New York | 10016 | United States |
|
| Weill Cornell Medicine - Pediatric | Withdrawn | New York | New York | 10021 | United States |
| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Gastroenterology Group of Rochester, LLP | Completed | Rochester | New York | 14618 | United States |
| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Temple University | Active, not recruiting | Philadelphia | Pennsylvania | 19140 | United States |
| Brown University Women's Medicine and Collaborative | Active, not recruiting | Providence | Rhode Island | 02904 | United States |
| Vanderbilt University Medical Center | Active, not recruiting | Nashville | Tennessee | 37232 | United States |
| Texas Children's Hospital / Baylor College of Medicine | Withdrawn | Houston | Texas | 77030 | United States |
| Baylor Research Institute - Scott & White Medical Center | Completed | Temple | Texas | 76508 | United States |
| West Virginia University | Not yet recruiting | Morgantown | West Virginia | 26506 | United States |
|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
|
| The Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| University of Alberta | Withdrawn | Edmonton | Alberta | T6G2X8 | Canada |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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