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AzTrials

Acute PancreatitisPhase 1NCT02318147

Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

A Phase 1 study testing Fecal Microbiota Transplantation and The traditional treatment in people with Acute Pancreatitis and Fecal Microbiota Transplantation, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Fecal Microbiota Transplantation and The traditional treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Nov 2016to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  • Pregnancy and lactation women
  • Not signed the informed consent

Trial locations and contacts

1 site in 1 country.

Yin Zhu, MD contact

13970841464

zhuyin27@sina.com

Lingyu Luo, MD contact

15270855639

15270855639@163.com

China1 site, 1 recruiting

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Nonghua Lv, MD, 13707086809, lunonghua@163.com

    Kunhe Zhang, MD, 13007202818, 393467260@qq.com

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Fecal Microbiota Transplantation, The traditional treatment
Keywords
Severe acute pancreatitis, Fecal Microbiota Transplantation, Bacterial Translocation, Infectious Complications
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantationProcedure or surgery

    Also called Fecal Microbiota Therapy, Fecal Transplantation

    FMT by retention enema with fresh bacteria from healthy donor

  • The traditional treatmentDrug

    Also called Conventional drugs according to the guideline

    the traditional treatments according to associated guidelines

Study groups in NCT02318147
Study groupRoleWhat they receive
Fecal Microbiota TransplantationExperimentalFMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
Receives: Procedure: Fecal Microbiota Transplantation; Drug: The traditional treatment
The traditional treatmentOtherThe traditional treatment of SAP according to the associated guidelines
Receives: Drug: The traditional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The control of infectious complications

    The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.

    Measured: From admission to discharge

Secondary outcomes (4)

  1. C-reactive protein（CRP）level

    C-reactive protein (CRP) is a inflammatory prognostic marker

    Measured: 1day before intervention，7days and 14days after intervention

  2. Procalcitionin（PCT）level

    Procalcitionin（PCT）level is a inflammatory prognostic marker

    Measured: 1day before intervention，7days and 14days after intervention

  3. Length of Intensive care time and hospital stay

    The time of stay in the intensive care unit and hospital

    Measured: From admission to discharge

  4. Mortality

    The incidence of death during the time frame

    Measured: From admission to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318147
Sponsor's protocol ID
NanchanguniversityII
Status last verified
Oct 2017
First submitted
12 Dec 2014
Last updated
18 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25389085

  • 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.

    PubMed 25373588

  • 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.

    PubMed 25345825

  • 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.

    PubMed 19801929

  • 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.

    PubMed 25043372

  • 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.

    PubMed 23660099

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

    PubMed 17599012

  • 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.

    PubMed 23152810

  • 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.

    PubMed 24976806

  • 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.

    PubMed 24939885

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fecal Microbiota Transplantation and The traditional treatment in people with Acute Pancreatitis and Fecal Microbiota Transplantation, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yin Zhu, MD (13970841464, zhuyin27@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The control of infectious complications (time frame: From admission to discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318147, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.

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