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Trial record 6 of 89 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

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ClinicalTrials.gov Identifier: NCT02318147
Recruitment Status : Recruiting
First Posted : December 17, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Lingyu Luo, The First Affiliated Hospital of Nanchang University

Brief Summary:
Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.The purpose of this clinical trail is to observe the potential capability of FMT in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Fecal Microbiota Transplantation Bacterial Translocation Infectious Complications Procedure: Fecal Microbiota Transplantation Drug: The traditional treatment Phase 1

Detailed Description:
Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus minimizing bacterial translocation and alleviating infectious complications. The investigators will further examine the effect of FMT on the incidence of infectious complications,duration of clinical course and mortality.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 Infectious Complications
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

The traditional treatment
The traditional treatment of SAP according to the associated guidelines
Drug: The traditional treatment
the traditional treatments according to associated guidelines
Other Name: Conventional drugs according to the guideline




Primary Outcome Measures :
  1. The control of infectious complications [ Time Frame: From admission to discharge ]
    The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.


Secondary Outcome Measures :
  1. C-reactive protein(CRP)level [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    C-reactive protein (CRP) is a inflammatory prognostic marker

  2. Procalcitionin(PCT)level [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    Procalcitionin(PCT)level is a inflammatory prognostic marker

  3. Length of Intensive care time and hospital stay [ Time Frame: From admission to discharge ]
    The time of stay in the intensive care unit and hospital

  4. Mortality [ Time Frame: From admission to discharge ]
    The incidence of death during the time frame



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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 severe 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 more than 2 weeks
  3. Intestinal bacterium screening tips gut dysbacteriosis
  4. Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.

Exclusion Criteria:

  1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  2. Pregnancy and lactation women
  3. Not signed the informed consent

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): NCT02318147


Contacts
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Contact: Yin Zhu, MD 13970841464 zhuyin27@sina.com
Contact: Lingyu Luo, MD 15270855639 15270855639@163.com

Locations
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China, Jiangxi
the First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Nonghua Lv, MD    13707086809    lunonghua@163.com   
Contact: Kunhe Zhang, MD    13007202818    393467260@qq.com   
Principal Investigator: Nonghua Lv, MD         
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

Publications:

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Responsible Party: Lingyu Luo, Physician-in-charge, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT02318147     History of Changes
Other Study ID Numbers: NanchanguniversityII
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Keywords provided by Lingyu Luo, The First Affiliated Hospital of Nanchang University:
Severe acute pancreatitis
Fecal Microbiota Transplantation
Bacterial Translocation
Infectious Complications
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Pancreatitis
Pancreatic Diseases
Digestive System Diseases