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Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Primary Purpose

Acute Pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
The traditional treatment
Sponsored by
The First Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Severe acute pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Fecal Microbiota Transplantation

The traditional treatment

Arm Description

FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP

The traditional treatment of SAP according to the associated guidelines

Outcomes

Primary Outcome Measures

The control of infectious complications
The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.

Secondary Outcome Measures

C-reactive protein（CRP）level
C-reactive protein (CRP) is a inflammatory prognostic marker
Procalcitionin（PCT）level
Procalcitionin（PCT）level is a inflammatory prognostic marker
Length of Intensive care time and hospital stay
The time of stay in the intensive care unit and hospital
Mortality
The incidence of death during the time frame

Full Information

First Posted
December 12, 2014
Last Updated
October 16, 2017
Sponsor
The First Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT02318147
Brief Title
Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)
Official Title
Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Nanchang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications
Keywords
Severe acute pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal Microbiota Transplantation
Arm Type
Experimental
Arm Description
FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
Arm Title
The traditional treatment
Arm Type
Other
Arm Description
The traditional treatment of SAP according to the associated guidelines
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Fecal Microbiota Therapy, Fecal Transplantation
Intervention Description
FMT by retention enema with fresh bacteria from healthy donor
Intervention Type
Drug
Intervention Name(s)
The traditional treatment
Other Intervention Name(s)
Conventional drugs according to the guideline
Intervention Description
the traditional treatments according to associated guidelines
Primary Outcome Measure Information:
Title
The control of infectious complications
Description
The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.
Time Frame
From admission to discharge
Secondary Outcome Measure Information:
Title
C-reactive protein（CRP）level
Description
C-reactive protein (CRP) is a inflammatory prognostic marker
Time Frame
1day before intervention，7days and 14days after intervention
Title
Procalcitionin（PCT）level
Description
Procalcitionin（PCT）level is a inflammatory prognostic marker
Time Frame
1day before intervention，7days and 14days after intervention
Title
Length of Intensive care time and hospital stay
Description
The time of stay in the intensive care unit and hospital
Time Frame
From admission to discharge
Title
Mortality
Description
The incidence of death during the time frame
Time Frame
From admission to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Onset of pancreatitis more than 2 weeks Intestinal bacterium screening tips gut dysbacteriosis Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients. Exclusion Criteria: SAP complicated by Gastrointestinal bleeding or Intestinal fistula Pregnancy and lactation women Not signed the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin Zhu, MD
Phone
13970841464
Email
zhuyin27@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingyu Luo, MD
Phone
15270855639
Email
15270855639@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD
Organizational Affiliation
the Frist Affiliated Hospital of Nanchang University
Official's Role
Study Chair
Facility Information:
Facility Name
the First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD
Phone
13707086809
Email
lunonghua@163.com
First Name & Middle Initial & Last Name & Degree
Kunhe Zhang, MD
Phone
13007202818
Email
393467260@qq.com
First Name & Middle Initial & Last Name & Degree
Nonghua Lv, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25389085
Citation
Liang J, Sha SM, Wu KC. Role of the intestinal microbiota and fecal transplantation in inflammatory bowel diseases. J Dig Dis. 2014 Dec;15(12):641-6. doi: 10.1111/1751-2980.12211.
Results Reference
background
PubMed Identifier
25373588
Citation
Li Q, Wang C, Tang C, He Q, Zhao X, Li N, Li J. Therapeutic modulation and reestablishment of the intestinal microbiota with fecal microbiota transplantation resolves sepsis and diarrhea in a patient. Am J Gastroenterol. 2014 Nov;109(11):1832-4. doi: 10.1038/ajg.2014.299. No abstract available.
Results Reference
background
PubMed Identifier
25345825
Citation
Peterson CT, Sharma V, Elmen L, Peterson SN. Immune homeostasis, dysbiosis and therapeutic modulation of the gut microbiota. Clin Exp Immunol. 2015 Mar;179(3):363-77. doi: 10.1111/cei.12474.
Results Reference
background
PubMed Identifier
19801929
Citation
Besselink MG, van Santvoort HC, Renooij W, de Smet MB, Boermeester MA, Fischer K, Timmerman HM, Ahmed Ali U, Cirkel GA, Bollen TL, van Ramshorst B, Schaapherder AF, Witteman BJ, Ploeg RJ, van Goor H, van Laarhoven CJ, Tan AC, Brink MA, van der Harst E, Wahab PJ, van Eijck CH, Dejong CH, van Erpecum KJ, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group. Intestinal barrier dysfunction in a randomized trial of a specific probiotic composition in acute pancreatitis. Ann Surg. 2009 Nov;250(5):712-9. doi: 10.1097/SLA.0b013e3181bce5bd.
Results Reference
background
PubMed Identifier
25043372
Citation
Gu WJ, Liu JC. Probiotics in patients with severe acute pancreatitis. Crit Care. 2014 Jul 3;18(4):446. doi: 10.1186/cc13968. No abstract available.
Results Reference
background
PubMed Identifier
23660099
Citation
Cui LH, Wang XH, Peng LH, Yu L, Yang YS. [The effects of early enteral nutrition with addition of probiotics on the prognosis of patients suffering from severe acute pancreatitis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2013 Apr;25(4):224-8. doi: 10.3760/cma.j.issn.2095-4352.2013.04.011. Chinese.
Results Reference
background
PubMed Identifier
17599012
Citation
Tellado JM. Prevention of infection following severe acute pancreatitis. Curr Opin Crit Care. 2007 Aug;13(4):416-20. doi: 10.1097/MCC.0b013e32826388b2.
Results Reference
background
PubMed Identifier
23152810
Citation
Hooijmans CR, de Vries RB, Rovers MM, Gooszen HG, Ritskes-Hoitinga M. The effects of probiotic supplementation on experimental acute pancreatitis: a systematic review and meta-analysis. PLoS One. 2012;7(11):e48811. doi: 10.1371/journal.pone.0048811. Epub 2012 Nov 13.
Results Reference
background
PubMed Identifier
24976806
Citation
Aroniadis OC, Brandt LJ. Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. Gastroenterol Hepatol (N Y). 2014 Apr;10(4):230-7.
Results Reference
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PubMed Identifier
24939885
Citation
Seekatz AM, Aas J, Gessert CE, Rubin TA, Saman DM, Bakken JS, Young VB. Recovery of the gut microbiome following fecal microbiota transplantation. mBio. 2014 Jun 17;5(3):e00893-14. doi: 10.1128/mBio.00893-14.
Results Reference
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Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

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