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Trial record 18 of 91 for:    Recruiting Studies | fecal microbiota transplantation

Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

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ClinicalTrials.gov Identifier: NCT03895593
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Xinjiang Medical University
Second Affiliated Hospital of Suzhou University
First Affiliated Hospital of Guangxi Medical University
Shenzhen Hospital of Southern Medical University
Wuhan University
Liuzhou People's Hospital
Lishui Country People's Hospital
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

Brief Summary:
A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the Chinese fmtBank designed to assess the short-term and long-term safety and efficacy.

Condition or disease Intervention/treatment
Intestinal Infection Clostridium Difficile Infection Antibiotic-associated Diarrhea Other: rescue fecal microbiota transplantation

Detailed Description:
This registry will enroll national patients with refractory intestinal infections receiving rescue fecal microbiota transplantation (FMT) from the Chinese fmtBank, from September 2015 to February 2019. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records. All the patients will be followed up for at least 12 weeks post-FMT. Information on follow-up will be designed to assess the short-term and long-term adverse events.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement


Intervention Details:
  • Other: rescue fecal microbiota transplantation
    Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract.


Primary Outcome Measures :
  1. 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.

  2. survival outcome [ Time Frame: 4 weeks ]
    The survival outcome refers to the 4-week survival post-FMT.


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 12 weeks ]
    Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to February, 2019 will be included
Criteria

Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September 2015 to February 2019 will be included.

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Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.

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Information from the National Library of Medicine

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


Contacts
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Contact: faming zhang, MD,PhD 086-025-58509883 fzhang@njmu.edu.cn
Contact: bota cui, MD,PhD 086-025-58509884 cuibota@njmu.edu.cn

Locations
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China, Jiangsu
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    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Xinjiang Medical University
Second Affiliated Hospital of Suzhou University
First Affiliated Hospital of Guangxi Medical University
Shenzhen Hospital of Southern Medical University
Wuhan University
Liuzhou People's Hospital
Lishui Country People's Hospital
Investigators
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Principal Investigator: faming zhang, MD,PhD The Second Hospital of Nanjing Medical University

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03895593     History of Changes
Other Study ID Numbers: FMT-CN-190321
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Nanjing Medical University:
fecal microbiota transplantation
intestinal infection
Clostridium Difficile Infection
Antibiotic-associated Diarrhea
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Trematode Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Helminthiasis
Parasitic Diseases