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Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)

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ClinicalTrials.gov Identifier: NCT03015467
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Chengdu Medical College

Brief Summary:
Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis,and the main pathogens from intestinal micro-organisms, but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Intestinal Bacteria Flora Disturbance Intestinal Dysfunction Fecal Microbiota Transplantation Other: Fecal Microbiota Transplantation Other: normal saline Phase 1 Phase 2

Detailed Description:
Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors,and fecal microbiota samples will be detection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: treatment for part 1
Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.
Other: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
Other Name: Fecal Microbiota Transplantation (FMT)

Placebo Comparator: Placebo for part 2
The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.
Other: normal saline
normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2
Other Name: normal saline (NS)




Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. C-reactive protein(CRP) [ Time Frame: 2-4 weeks ]
  2. Diamine oxidase(DAO) [ Time Frame: 2-4 weeks ]
  3. Interleukin [ Time Frame: 2-4 weeks ]
  4. tumor necrosis factor-a(TNF-a) [ Time Frame: 2-4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen;
  2. No chronic diseases of the digestive system ;
  3. No chronic diseases of the urinary system;
  4. No chronic metabolic disease;
  5. No chronic disease of immune system
  6. No chronic disease of mental disease
  7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;
  8. No use of addictive drugs and immune inhibitors

Exclusion Criteria:

  1. not to match the standard of AP
  2. with chronic diseases of the digestive system;
  3. with chronic diseases of the urinary system;
  4. with chronic metabolic disease;
  5. with chronic disease of immune system
  6. with chronic disease of mental disease
  7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women
  8. with use of addictive drugs and immune inhibitors
  9. exceed the age limits

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): NCT03015467


Contacts
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Contact: Li Fang, Ph.D +8613458555780 fangzjt@163.com
Contact: Yan Zhou, Ph.D +8618981941992 269000947@qq.com

Locations
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China
IEC of Chengdu Medical College Recruiting
Chendu, China, 610500
Contact: Xiao-an Li, post doctor    +8613680868858    zqzy1983@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chengdu Medical College
Investigators
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Study Chair: Li Fang, Ph.D First Affiliated Hospital of Chengdu Medical College

Publications:

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Responsible Party: First Affiliated Hospital of Chengdu Medical College
ClinicalTrials.gov Identifier: NCT03015467     History of Changes
Other Study ID Numbers: AM-FMT-SAP
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by First Affiliated Hospital of Chengdu Medical College:
acute pancreatitis
intestinal mucosal barrier
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases