Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03895593|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment|
|Intestinal Infection Clostridium Difficile Infection Antibiotic-associated Diarrhea||Other: rescue fecal microbiota transplantation|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry|
|Actual Study Start Date :||September 25, 2015|
|Estimated Primary Completion Date :||May 1, 2024|
|Estimated Study Completion Date :||May 1, 2029|
- Other: rescue fecal microbiota transplantation
Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract.
- abdominal symptom outcomes [ Time Frame: 1 week ]Definitions used to classify response, nonresponse and exacerbation for the abdominal symptom outcomes are based on the physicians' holistic evaluation of patients' abdominal symptoms.
- survival outcome [ Time Frame: 4 weeks ]The survival outcome refers to the 4-week survival post-FMT.
- adverse events [ Time Frame: 12 weeks ]Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895593
|Contact: faming zhang, MD,PhDfirstname.lastname@example.org|
|Contact: bota cui, MD,PhDemail@example.com|
|Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210011|
|Contact: Faming Zhang, MD, PhD 086-25-58509883 firstname.lastname@example.org|
|Principal Investigator:||faming zhang, MD,PhD||The Second Hospital of Nanjing Medical University|