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Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

NCT ID: NCT02318147

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Pancreatitis Fecal Microbiota Transplantation Bacterial Translocation Infectious Complications

Keywords

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Severe acute pancreatitis Fecal Microbiota Transplantation Bacterial Translocation Infectious Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fecal Microbiota Transplantation

FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type PROCEDURE

FMT by retention enema with fresh bacteria from healthy donor

The traditional treatment

Intervention Type DRUG

the traditional treatments according to associated guidelines

The traditional treatment

The traditional treatment of SAP according to the associated guidelines

Group Type OTHER

The traditional treatment

Intervention Type DRUG

the traditional treatments according to associated guidelines

Interventions

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Fecal Microbiota Transplantation

FMT by retention enema with fresh bacteria from healthy donor

Intervention Type PROCEDURE

The traditional treatment

the traditional treatments according to associated guidelines

Intervention Type DRUG

Other Intervention Names

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Fecal Microbiota Therapy Fecal Transplantation Conventional drugs according to the guideline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Lingyu Luo

Physician-in-charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nonghua Lv, MD

Role: STUDY_CHAIR

the Frist Affiliated Hospital of Nanchang University

Locations

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the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yin Zhu, MD

Role: CONTACT

Phone: 13970841464

Email: [email protected]

Lingyu Luo, MD

Role: CONTACT

Phone: 15270855639

Email: [email protected]

Facility Contacts

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Nonghua Lv, MD

Role: primary

Kunhe Zhang, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 25389085 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 25373588 (View on PubMed)

Peterson 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.

Reference Type BACKGROUND
PMID: 25345825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19801929 (View on PubMed)

Gu 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.

Reference Type BACKGROUND
PMID: 25043372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23660099 (View on PubMed)

Tellado JM. Prevention of infection following severe acute pancreatitis. Curr Opin Crit Care. 2007 Aug;13(4):416-20. doi: 10.1097/MCC.0b013e32826388b2.

Reference Type BACKGROUND
PMID: 17599012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23152810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24976806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24939885 (View on PubMed)

Other Identifiers

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NanchanguniversityII

Identifier Type: -

Identifier Source: org_study_id