Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Acute Pancreatitis Clinical Trial

Official title:

Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02318147
• Other study ID #: NanchanguniversityII
• Status: Recruiting
• Phase: Phase 1
• First received: December 12, 2014
• Last updated: October 16, 2017
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Yin Zhu, MD
• Phone: 13970841464
• Email: zhuyin27[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Bacterial Translocation
• Communicable Diseases
• Fecal Microbiota Transplantation
• Infection
• Infectious Complications
• Pancreatitis

Intervention

Procedure:
• Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor

Drug:
• The traditional treatment
the traditional treatments according to associated guidelines

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View Citation

Gu WJ, Liu JC. Probiotics in patients with severe acute pancreatitis. Crit Care. 2014 Jul 3;18(4):446. doi: 10.1186/cc13968. — View 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. Review. — View 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. — View 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. Review. — View Citation

Peterson CT, Sharma V, Elmén 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. Review. — View 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. — View Citation

Tellado JM. Prevention of infection following severe acute pancreatitis. Curr Opin Crit Care. 2007 Aug;13(4):416-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The control of infectious complications	The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.	From admission to discharge
Secondary	C-reactive protein(CRP)level	C-reactive protein (CRP) is a inflammatory prognostic marker	1day before intervention,7days and 14days after intervention
Secondary	Procalcitionin(PCT)level	Procalcitionin(PCT)level is a inflammatory prognostic marker	1day before intervention,7days and 14days after intervention
Secondary	Length of Intensive care time and hospital stay	The time of stay in the intensive care unit and hospital	From admission to discharge
Secondary	Mortality	The incidence of death during the time frame	From admission to discharge