Fecal Microbiota Transplantation for Pancreatitis (FMTP)
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|ClinicalTrials.gov Identifier: NCT02318134|
Recruitment Status : Completed
First Posted : December 17, 2014
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis Intestinal Bacteria Flora Disturbance Intestinal Dysfunction Fecal Microbiota Transplantation||Procedure: Fecal Microbiota Transplantation Drug: normal saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction|
|Actual Study Start Date :||November 18, 2017|
|Actual Primary Completion Date :||April 17, 2019|
|Actual Study Completion Date :||December 18, 2019|
Experimental: FMT group
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
Procedure: Fecal Microbiota Transplantation
FMT via a nasoduodenal tube with fresh bacteria from healthy donor
Placebo Comparator: Control group
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
Drug: normal saline
Normal saline via a nasoduodenal tube.
Other Name: normal saline 0.9%
- Number of Participants With Gastrointestinal Failure Score Equal 0 [ Time Frame: one week after intervention ]The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.
- Number of Participants With Infectious Complications [ Time Frame: 120 days ]The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
- Number of Participants With Organ Failure [ Time Frame: 120 days ]The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
- Number of Participants With Interventions or Surgery [ Time Frame: 120 days ]number of patients who need extra interventions or surgery
- Length of Intensive Care Time and Hospital Stay [ Time Frame: 6 months ]patients' Length of Intensive care time and hospital stay due to the disease
- Mortality [ Time Frame: 120 days ]patients who die due to the diseases
- Diamine Oxidase（DAO） [ Time Frame: one week after intervention ]Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100)
- D-lactate [ Time Frame: one week after intervention ]Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100).
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): NCT02318134
|the First Affiliated Hospital of Nanchang University|
|Nanchang, Jiangxi, China, 330006|
|Study Chair:||Nonghua Lv, MD||the Frist Affiliated Hospital of Nanchang University|