Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 89 for:    Recruiting Studies | fecal microbiota transplantation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Mortality [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03015467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • C-reactive protein(CRP) [ Time Frame: 2-4 weeks ]
  • Diamine oxidase(DAO) [ Time Frame: 2-4 weeks ]
  • Interleukin [ Time Frame: 2-4 weeks ]
  • tumor necrosis factor-a(TNF-a) [ Time Frame: 2-4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)
Official Title  ICMJE Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pancreatitis
  • Intestinal Bacteria Flora Disturbance
  • Intestinal Dysfunction
  • Fecal Microbiota Transplantation
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Other: Fecal Microbiota Transplantation
  • 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.
    Intervention: Other: normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Li Fang, Ph.D +8613458555780 fangzjt@163.com
Contact: Yan Zhou, Ph.D +8618981941992 269000947@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015467
Other Study ID Numbers  ICMJE AM-FMT-SAP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Chengdu Medical College
Study Sponsor  ICMJE First Affiliated Hospital of Chengdu Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Li Fang, Ph.D First Affiliated Hospital of Chengdu Medical College
PRS Account First Affiliated Hospital of Chengdu Medical College
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP