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

Primary Purpose

Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Fecal Microbiota Transplantation

normal saline

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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;
No chronic diseases of the digestive system ;
No chronic diseases of the urinary system;
No chronic metabolic disease;
No chronic disease of immune system
No chronic disease of mental disease
no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;
No use of addictive drugs and immune inhibitors

Exclusion Criteria:

not to match the standard of AP
with chronic diseases of the digestive system;
with chronic diseases of the urinary system;
with chronic metabolic disease;
with chronic disease of immune system
with chronic disease of mental disease
with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women
with use of addictive drugs and immune inhibitors
exceed the age limits

Sites / Locations

IEC of Chengdu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment for part 1

Placebo for part 2

Arm Description

Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.

The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

C-reactive protein（CRP）

Diamine oxidase（DAO）

Interleukin

tumor necrosis factor-a(TNF-a)

Full Information

NCT ID

NCT03015467

First Posted

January 3, 2017

Last Updated

January 10, 2017

Sponsor

First Affiliated Hospital of Chengdu Medical College

1. Study Identification

Unique Protocol Identification Number

NCT03015467

Brief Title

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

Official Title

Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Chengdu Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment for part 1

Arm Type

Active Comparator

Arm Description

Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.

Arm Title

Placebo for part 2

Arm Type

Placebo Comparator

Arm Description

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 Type

Other

Intervention Name(s)

Fecal Microbiota Transplantation

Other Intervention Name(s)

Fecal Microbiota Transplantation (FMT)

Intervention Description

Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1

Intervention Type

Other

Intervention Name(s)

normal saline

Other Intervention Name(s)

normal saline (NS)

Intervention Description

normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2

Primary Outcome Measure Information:

Title

Mortality

Time Frame

3 months

Secondary Outcome Measure Information:

Title

C-reactive protein（CRP）

Time Frame

2-4 weeks

Title

Diamine oxidase（DAO）

Time Frame

2-4 weeks

Title

Interleukin

Time Frame

2-4 weeks

Title

tumor necrosis factor-a(TNF-a)

Time Frame

2-4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; No chronic diseases of the digestive system ; No chronic diseases of the urinary system; No chronic metabolic disease; No chronic disease of immune system No chronic disease of mental disease no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month; No use of addictive drugs and immune inhibitors Exclusion Criteria: not to match the standard of AP with chronic diseases of the digestive system; with chronic diseases of the urinary system; with chronic metabolic disease; with chronic disease of immune system with chronic disease of mental disease with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women with use of addictive drugs and immune inhibitors exceed the age limits

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Fang, Ph.D

Phone

+8613458555780

fangzjt@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Zhou, Ph.D

Phone

+8618981941992

269000947@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Fang, Ph.D

Organizational Affiliation

First Affiliated Hospital of Chengdu Medical College

Official's Role

Study Chair

Facility Information:

Facility Name

IEC of Chengdu Medical College

City

Chendu

ZIP/Postal Code

610500

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiao-an Li, post doctor

Phone

+8613680868858

zqzy1983@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21206096

Citation

Noor MT, Radhakrishna Y, Kochhar R, Ray P, Wig JD, Sinha SK, Singh K. Bacteriology of infection in severe acute pancreatitis. JOP. 2011 Jan 5;12(1):19-25.

Results Reference

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PubMed Identifier

25234043

Citation

Murphy SF, Rhee L, Grimm WA, Weber CR, Messer JS, Lodolce JP, Chang JE, Bartulis SJ, Nero T, Kukla RA, MacDougall G, Binghay C, Kolodziej LE, Boone DL. Intestinal epithelial expression of TNFAIP3 results in microbial invasion of the inner mucus layer and induces colitis in IL-10-deficient mice. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 1;307(9):G871-82. doi: 10.1152/ajpgi.00020.2014. Epub 2014 Sep 18.

Results Reference

background

PubMed Identifier

25334028

Citation

Wu LM, Sankaran SJ, Plank LD, Windsor JA, Petrov MS. Meta-analysis of gut barrier dysfunction in patients with acute pancreatitis. Br J Surg. 2014 Dec;101(13):1644-56. doi: 10.1002/bjs.9665. Epub 2014 Oct 21.

Results Reference

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PubMed Identifier

24978882

Citation

Fishman JE, Levy G, Alli V, Zheng X, Mole DJ, Deitch EA. The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis. Shock. 2014 Sep;42(3):264-70. doi: 10.1097/SHK.0000000000000209.

Results Reference

background

PubMed Identifier

25872170

Citation

Schwender BJ, Gordon SR, Gardner TB. Risk factors for the development of intra-abdominal fungal infections in acute pancreatitis. Pancreas. 2015 Jul;44(5):805-7. doi: 10.1097/MPA.0000000000000334.

Results Reference

background

PubMed Identifier

25003605

Citation

Hall JC, Crawford HC. The conspiracy of autophagy, stress and inflammation in acute pancreatitis. Curr Opin Gastroenterol. 2014 Sep;30(5):495-9. doi: 10.1097/MOG.0000000000000097.

Results Reference

background

PubMed Identifier

26730036

Citation

Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal A, Kozak O. The Effects of Total Colectomy on Bacterial Translocation in a Model of Acute Pancreatitis. Indian J Surg. 2015 Dec;77(Suppl 2):412-8. doi: 10.1007/s12262-013-0855-y. Epub 2013 Jan 31.

Results Reference

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PubMed Identifier

26744983

Citation

Bongaerts GP, Severijnen RS. A reassessment of the PROPATRIA study and its implications for probiotic therapy. Nat Biotechnol. 2016 Jan;34(1):55-63. doi: 10.1038/nbt.3436.

Results Reference

background

PubMed Identifier

21327117

Citation

Hansson GC, Johansson ME. The inner of the two Muc2 mucin-dependent mucus layers in colon is devoid of bacteria. Gut Microbes. 2010 Jan;1(1):51-54. doi: 10.4161/gmic.1.1.10470.

Results Reference

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PubMed Identifier

18257123

Citation

Zhang XP, Zhang J, Song QL, Chen HQ. Mechanism of acute pancreatitis complicated with injury of intestinal mucosa barrier. J Zhejiang Univ Sci B. 2007 Dec;8(12):888-95. doi: 10.1631/jzus.2007.B0888.

Results Reference

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

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