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Fecal Microbiota Transplantation for Pancreatitis (FMTP)

Primary Purpose

Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
normal saline
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, Intestinal barrier dysfunction, Intestinal flora

Eligibility Criteria

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

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. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

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
  5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

Sites / Locations

  • the First Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMT group

Control group

Arm Description

In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.

In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.

Outcomes

Primary Outcome Measures

Number of Participants With Gastrointestinal Failure Score Equal 0
The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. 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. GIF score range from 0 to 4, and higher scores mean a worse outcome.

Secondary Outcome Measures

Number of Participants With Infectious Complications
The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
Number of Participants With Organ Failure
The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
Number of Participants With Interventions or Surgery
number of patients who need extra interventions or surgery
Length of Intensive Care Time and Hospital Stay
patients' Length of Intensive care time and hospital stay due to the disease
Mortality
patients who die due to the diseases
Diamine Oxidase（DAO）
Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100)
D-lactate
Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100).

Full Information

First Posted
December 12, 2014
Last Updated
March 19, 2021
Sponsor
The First Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT02318134
Brief Title
Fecal Microbiota Transplantation for Pancreatitis
Acronym
FMTP
Official Title
Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2017 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction, Fecal Microbiota Transplantation
Keywords
Severe acute pancreatitis, Fecal Microbiota Transplantation, Intestinal barrier dysfunction, Intestinal flora

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT group
Arm Type
Experimental
Arm Description
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Fecal Microbiota Therapy, Fecal Transplantation
Intervention Description
FMT via a nasoduodenal tube with fresh bacteria from healthy donor
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
normal saline 0.9%
Intervention Description
Normal saline via a nasoduodenal tube.
Primary Outcome Measure Information:
Title
Number of Participants With Gastrointestinal Failure Score Equal 0
Description
The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. 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. GIF score range from 0 to 4, and higher scores mean a worse outcome.
Time Frame
one week after intervention
Secondary Outcome Measure Information:
Title
Number of Participants With Infectious Complications
Description
The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
Time Frame
120 days
Title
Number of Participants With Organ Failure
Description
The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
Time Frame
120 days
Title
Number of Participants With Interventions or Surgery
Description
number of patients who need extra interventions or surgery
Time Frame
120 days
Title
Length of Intensive Care Time and Hospital Stay
Description
patients' Length of Intensive care time and hospital stay due to the disease
Time Frame
6 months
Title
Mortality
Description
patients who die due to the diseases
Time Frame
120 days
Title
Diamine Oxidase（DAO）
Description
Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100)
Time Frame
one week after intervention
Title
D-lactate
Description
Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100).
Time Frame
one week after intervention

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 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 within <=2 weeks complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension. Exclusion Criteria: SAP complicated by Gastrointestinal bleeding or Intestinal fistula Pregnancy and lactation women Not signed the informed consent Diabetes and autoimmune diseases Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18376312
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
22310869
Citation
Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.
Results Reference
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PubMed Identifier
21682755
Citation
Landy J, Al-Hassi HO, McLaughlin SD, Walker AW, Ciclitira PJ, Nicholls RJ, Clark SK, Hart AL. Review article: faecal transplantation therapy for gastrointestinal disease. Aliment Pharmacol Ther. 2011 Aug;34(4):409-15. doi: 10.1111/j.1365-2036.2011.04737.x. Epub 2011 Jun 20.
Results Reference
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PubMed Identifier
24018052
Citation
Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
Results Reference
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PubMed Identifier
23642791
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Singh R, Nieuwdorp M, ten Berge IJ, Bemelman FJ, Geerlings SE. The potential beneficial role of faecal microbiota transplantation in diseases other than Clostridium difficile infection. Clin Microbiol Infect. 2014 Nov;20(11):1119-25. doi: 10.1111/1469-0691.12799. Epub 2014 Nov 7.
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PubMed Identifier
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Citation
Allegretti JR, Hamilton MJ. Restoring the gut microbiome for the treatment of inflammatory bowel diseases. World J Gastroenterol. 2014 Apr 7;20(13):3468-74. doi: 10.3748/wjg.v20.i13.3468.
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Citation
Shankar V, Hamilton MJ, Khoruts A, Kilburn A, Unno T, Paliy O, Sadowsky MJ. Species and genus level resolution analysis of gut microbiota in Clostridium difficile patients following fecal microbiota transplantation. Microbiome. 2014 Apr 21;2:13. doi: 10.1186/2049-2618-2-13. eCollection 2014.
Results Reference
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PubMed Identifier
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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
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Citation
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Results Reference
derived
Links:
URL
http://www.cdyfy.com/
Description
the First Affiliated Hospital of Nanchang University

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Fecal Microbiota Transplantation for Pancreatitis

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