Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 18, 2017
October 1, 2017
2.1 years
December 12, 2014
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
C-reactive protein（CRP）level
1day before intervention，7days and 14days after intervention
Procalcitionin（PCT）level
1day before intervention，7days and 14days after intervention
Length of Intensive care time and hospital stay
From admission to discharge
Mortality
From admission to discharge
Study Arms (2)
Fecal Microbiota Transplantation
EXPERIMENTALFMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
The traditional treatment
OTHERThe traditional treatment of SAP according to the associated guidelines
Interventions
FMT by retention enema with fresh bacteria from healthy donor
the traditional treatments according to associated guidelines
Eligibility Criteria
You may qualify if:
- 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
- Onset of pancreatitis more than 2 weeks
- Intestinal bacterium screening tips gut dysbacteriosis
- Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.
You may not qualify if:
- SAP complicated by Gastrointestinal bleeding or Intestinal fistula
- Pregnancy and lactation women
- Not signed the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Related Publications (10)
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.
PMID: 25389085BACKGROUNDLi 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. No abstract available.
PMID: 25373588BACKGROUNDPeterson CT, Sharma V, Elmen 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.
PMID: 25345825BACKGROUNDBesselink 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.
PMID: 19801929BACKGROUNDGu WJ, Liu JC. Probiotics in patients with severe acute pancreatitis. Crit Care. 2014 Jul 3;18(4):446. doi: 10.1186/cc13968. No abstract available.
PMID: 25043372BACKGROUNDCui 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.
PMID: 23660099BACKGROUNDTellado JM. Prevention of infection following severe acute pancreatitis. Curr Opin Crit Care. 2007 Aug;13(4):416-20. doi: 10.1097/MCC.0b013e32826388b2.
PMID: 17599012BACKGROUNDHooijmans 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.
PMID: 23152810BACKGROUNDAroniadis 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.
PMID: 24976806BACKGROUNDSeekatz 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.
PMID: 24939885BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nonghua Lv, MD
the Frist Affiliated Hospital of Nanchang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician-in-charge
Study Record Dates
First Submitted
December 12, 2014
First Posted
December 17, 2014
Study Start
November 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 18, 2017
Record last verified: 2017-10