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NCT Number: NCT03895593

Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the China Microbiota Transplantation System was designed to assess the short-term and long-term safety and efficacy.

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Key information

Conditions

Intestinal Infection Antibiotic-associated Diarrhea Bacterial Infections Bacterial Infections and Mycoses Clostridioides Difficile Infection Clostridium Infections Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location status: Recruiting

Location contact

Faming Zhang, MD, PhD

CONTACT

[email protected]

086-25-58509883

About this study

This registry will enroll national patients with refractory intestinal infections (including clostridioides difficile infection, other infections with known or unknown pathogens) receiving rescue fecal microbiota transplantation (FMT) from the the China Microbiota Transplantation System. The improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the consensus statement from the FMT-standardization study group in 2019.12. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records or prospective follow-up. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 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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Treatment and study plan

rescue fecal microbiota transplantation

Other

Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract. The delivering ways for FMT include but are not limited to gastroscopy, colonoscopy, edema, nasogastric tube, transendoscopic enteral tube, and etc.

Primary outcomes

  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.

  3. clinical cure of clostridioides difficile infection

    Time frame: 8 weeks

    clinical resolution (absence of diarrhea, or marked reduction in stool frequency), or a negative clostridioides difficile (CD) test, without the need for further anti-clostridioides difficile infection therapy

Secondary outcomes

  1. adverse events

    Time frame: 12 weeks

    Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.

Study contacts

Contact information is provided by the study sponsor or research team.

bota cui, MD,PhD

CONTACT

[email protected]

086-025-58509884

faming zhang, MD,PhD

CONTACT

[email protected]

086-025-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Lishui Country People's Hospital
  • LiuZhou People's Hospital
  • Second Affiliated Hospital of Suzhou University
  • Shenzhen Hospital of Southern Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan University

Registry information

Official study title

Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry

Important dates

Study start
2015
Primary completion
2024
Study completion
2029
First posted
Mar 29, 2019
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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