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

NCT03015467 | Unknown Phase 1 DMC

• 1 other identifier: AM-FMT-SAP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction; Fecal Microbiota Transplantation

Keywords

acute pancreatitis; intestinal mucosal barrier; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Mortality

  3 months

Secondary Outcomes (4)

• C-reactive protein（CRP）

  2-4 weeks

• Diamine oxidase（DAO）

  2-4 weeks

• Interleukin

  2-4 weeks

• tumor necrosis factor-a(TNF-a)

  2-4 weeks

Study Arms (2)

treatment for part 1

ACTIVE COMPARATOR

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

Other: Fecal Microbiota Transplantation

Placebo for part 2

PLACEBO COMPARATOR

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

Other: normal saline

Interventions

Fecal Microbiota Transplantation OTHER

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

Also known as: Fecal Microbiota Transplantation (FMT)

treatment for part 1

normal saline OTHER

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

Also known as: normal saline (NS)

Placebo for part 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Study Sites (1)

IEC of Chengdu Medical College

Chendu, 610500, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 21206096 BACKGROUND

• 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.

  PMID: 25234043 BACKGROUND

• 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.

  PMID: 25334028 BACKGROUND

• 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.

  PMID: 24978882 BACKGROUND

• 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.

  PMID: 25872170 BACKGROUND

• 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.

  PMID: 25003605 BACKGROUND

• 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.

  PMID: 26730036 BACKGROUND

• 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.

  PMID: 26744983 BACKGROUND

• 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.

  PMID: 21327117 BACKGROUND

• 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.

  PMID: 18257123 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Fecal Microbiota Transplantation; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Li Fang, Ph.D

  First Affiliated Hospital of Chengdu Medical College

  STUDY CHAIR

Central Study Contacts

Li Fang, Ph.D

CONTACT

+8613458555780; fangzjt@163.com

Yan Zhou, Ph.D

CONTACT

+8618981941992; 269000947@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 10, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)