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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
Sponsor:
Information provided by (Responsible Party):
Lingyu Luo, The First Affiliated Hospital of Nanchang University

Brief Summary:
The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

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

Detailed Description:
Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers,the predictors of Intestinal barrier injury and the incidence of infectious complications.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Fecal Microbiota Therapy
  • Fecal Transplantation

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%




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of Participants With Organ Failure [ Time Frame: 120 days ]
    The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.

  3. Number of Participants With Interventions or Surgery [ Time Frame: 120 days ]
    number of patients who need extra interventions or surgery

  4. 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

  5. Mortality [ Time Frame: 120 days ]
    patients who die due to the diseases

  6. 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)

  7. 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
  2. Onset of pancreatitis within <=2 weeks
  3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria:

  1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  2. Pregnancy and lactation women
  3. Not signed the informed consent
  4. Diabetes and autoimmune diseases
  5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

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): NCT02318134


Locations
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China, Jiangxi
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Sponsors and Collaborators
The First Affiliated Hospital of Nanchang University
Investigators
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Study Chair: Nonghua Lv, MD the Frist Affiliated Hospital of Nanchang University
  Study Documents (Full-Text)

Documents provided by Lingyu Luo, The First Affiliated Hospital of Nanchang University:
Additional Information:
Publications:

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Responsible Party: Lingyu Luo, Physician-in-charge, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT02318134    
Other Study ID Numbers: Nanchanguniversity
First Posted: December 17, 2014    Key Record Dates
Results First Posted: April 14, 2021
Last Update Posted: April 14, 2021
Last Verified: March 2021

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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 Lingyu Luo, The First Affiliated Hospital of Nanchang University:
Severe acute pancreatitis
Fecal Microbiota Transplantation
Intestinal barrier dysfunction
Intestinal flora
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases