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Fecal Microbiota Transplantation for Pancreatitis (FMTP)

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ClinicalTrials.gov Identifier: NCT02318134
Recruitment Status : Unknown
Verified November 2017 by Lingyu Luo, The First Affiliated Hospital of Nanchang University.
Recruitment status was:  Recruiting
First Posted : December 17, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Lingyu Luo, The First Affiliated Hospital of Nanchang University

Tracking Information
First Submitted Date  ICMJE December 12, 2014
First Posted Date  ICMJE December 17, 2014
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE August 3, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Gastrointestinal Failure score [ Time Frame: everyday after intervention for 7 days or 14 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • C-reactive protein(CRP)level [ Time Frame: 72 hours ]
    C-reactive protein (CRP) is a inflammatory prognostic marker
  • Procalcitionin(PCT)level [ Time Frame: 72 hours ]
    Procalcitionin(PCT) is a inflammatory prognostic marker
  • Intra-Abdominal pressure(IAP) [ Time Frame: 24 hours ]
    Intra-abdominal pressure(IAP) level will be increased after intestinal barrier dysfunction
  • Diamine oxidase(DAO)level [ Time Frame: 1 week ]
    Diamine oxidase(DAO)level as a predictor in the diagnosis of Intestinal mucosal barrier injury
  • D-lactate level [ Time Frame: 1 week ]
    Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal barrier injury
  • Feces smear [ Time Frame: 1 week ]
    To evaluate the severity of intestinal dysbacteriosis
  • Pancreatic pseudocyst、walled—off necrosis、infected necrosis [ Time Frame: 1 month ]
    The incidence of pancreatic pseudocyst,walled-off necrosis and infected necrosis
Change History Complete list of historical versions of study NCT02318134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • The incidence of infectious complications [ Time Frame: up to 12 weeks ]
    The incidence of infectious complications,such as pancreatic pseudocyst、walled-off necrosis、infected necrosis、Bacteraemia、Infected ascites.
  • The incidence of organ failure [ Time Frame: up to 12 weeks ]
    The incidence of organ failure,such as acute respiratory failure,acute renal failure.
  • interventions or surgery [ Time Frame: up to 12 weeks ]
    patients needs extra interventions or surgery
  • Length of Intensive care time and hospital stay [ Time Frame: up to 12 weeks ]
    patients' Length of Intensive care time and hospital stay due to the disease
  • Mortality [ Time Frame: up to 12 weeks ]
    patients who die due to the diseases
  • the number of defecation [ Time Frame: up to 12 weeks ]
    the time to restore spontaneous defecation, after the daily number of defecation and defecation
  • Diamine oxidase(DAO) [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    Plasma Diamine oxidase(DAO)level as a predictor in the diagnosis of Intestinal mucosal barrier injury
  • D-lactate [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • The incidence of organ failure [ Time Frame: 2 weeks ]
    The incidence of organ failure,such as acute respiratory failure,acute renal failure.
  • Mortality [ Time Frame: 3 months ]
  • Intensive care time [ Time Frame: 2 months ]
  • Length of hospital stay [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Pancreatitis
Official Title  ICMJE Fecal Microbiota Transplantation in SAP(Severe Acute Pancreatitis)Patients With Intestinal Barrier Dysfunction
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pancreatitis
  • Intestinal Bacteria Flora Disturbance
  • Intestinal Dysfunction
  • Fecal Microbiota Transplantation
Intervention  ICMJE
  • Procedure: Fecal Microbiota Transplantation
    FMT by retention enema with fresh bacteria from healthy donor
    Other Names:
    • Fecal Microbiota Therapy
    • Fecal Transplantation
  • Drug: The traditional treatment
    the traditional treatments according to associated guidelines
    Other Name: Conventional drugs according to the guideline
Study Arms  ICMJE
  • Experimental: Fecal Microbiota Transplantation
    FMT by retention enema with fresh bacteria from healthy donor,At the same time give patients the traditional treatment of SAP
    Interventions:
    • Procedure: Fecal Microbiota Transplantation
    • Drug: The traditional treatment
  • The traditional treatment
    The traditional treatment of SAP according to the associated guidelines
    Intervention: Drug: The traditional treatment
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Gastrointestinal failure score (GIF score) >= 2 points. That is, food intolerance (due to high gastric retention, vomiting, flatulence or severe diarrhea) or intraperitoneal hypertension (≥ 12mmHg);

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02318134
Other Study ID Numbers  ICMJE Nanchanguniversity
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lingyu Luo, The First Affiliated Hospital of Nanchang University
Study Sponsor  ICMJE The First Affiliated Hospital of Nanchang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nonghua Lv, MD the Frist Affiliated Hospital of Nanchang University
PRS Account The First Affiliated Hospital of Nanchang University
Verification Date November 2017

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