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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03015467
• Other study ID #: AM-FMT-SAP
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2017
• Last updated: January 10, 2017
• Start date: December 2016
• Est. completion date: March 2020

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Li Fang, Ph.D
• Phone: +8613458555780
• Email: fangzjt[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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;

2. No chronic diseases of the digestive system ;

3. No chronic diseases of the urinary system;

4. No chronic metabolic disease;

5. No chronic disease of immune system

6. No chronic disease of mental disease

7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;

8. No use of addictive drugs and immune inhibitors

Exclusion Criteria:

1. not to match the standard of AP

2. with chronic diseases of the digestive system;

3. with chronic diseases of the urinary system;

4. with chronic metabolic disease;

5. with chronic disease of immune system

6. with chronic disease of mental disease

7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women

8. with use of addictive drugs and immune inhibitors

9. exceed the age limits

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Dysbiosis
• Fecal Microbiota Transplantation
• Intestinal Bacteria Flora Disturbance
• Intestinal Dysfunction
• Pancreatitis

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
• normal saline
normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2

Locations

Country	Name	City	State
China	IEC of Chengdu Medical College	Chendu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MÖ, Kiliç A, Günal 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		3 months	Yes
Secondary	C-reactive protein(CRP)		2-4 weeks	No
Secondary	Diamine oxidase(DAO)		2-4 weeks	No
Secondary	Interleukin		2-4 weeks	No
Secondary	tumor necrosis factor-a(TNF-a)		2-4 weeks	No