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Acute PancreatitisPhase 2FMTPNCT02318134

Fecal Microbiota Transplantation for Pancreatitis

A Phase 2 study testing Fecal Microbiota Transplantation and normal saline in people with Acute Pancreatitis and Intestinal Bacteria Flora Disturbance, run by The First Affiliated Hospital of Nanchang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Fecal Microbiota Transplantation and normal saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
18 Nov 2017to 18 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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 within <=2 weeks
  • complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Who cannot join

  • SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  • Pregnancy and lactation women
  • Not signed the informed consent
  • Diabetes and autoimmune diseases
  • Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

Other trials in China

About this study

Official title: Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction

The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

Read the detailed description

Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.

Being tested
Fecal Microbiota Transplantation, normal saline
Keywords
Severe acute pancreatitis, Fecal Microbiota Transplantation, Intestinal barrier dysfunction, Intestinal flora
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 via a nasoduodenal tube with fresh bacteria from healthy donor

  • normal salineDrug

    Also called normal saline 0.9%

    Normal saline via a nasoduodenal tube.

Study groups in NCT02318134
Study groupRoleWhat they receive
FMT groupExperimentalIn the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
Receives: Procedure: Fecal Microbiota Transplantation
Control groupPlacebo comparatorIn the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
Receives: Drug: normal saline

What is being measured

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

  1. Number of Participants With Gastrointestinal Failure Score Equal 0

    The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.

    Measured: one week after intervention

Secondary outcomes (7)

  1. Number of Participants With Infectious Complications

    The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.

    Measured: 120 days

  2. Number of Participants With Organ Failure

    The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.

    Measured: 120 days

  3. Number of Participants With Interventions or Surgery

    number of patients who need extra interventions or surgery

    Measured: 120 days

  4. Length of Intensive Care Time and Hospital Stay

    patients' Length of Intensive care time and hospital stay due to the disease

    Measured: 6 months

  5. Mortality

    patients who die due to the diseases

    Measured: 120 days

  6. Diamine Oxidase（DAO）

    Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100)

    Measured: one week after intervention

  7. D-lactate

    Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100).

    Measured: one week after intervention

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 start18 Nov 2017
  3. Primary completion17 Apr 2019
  4. Study completion18 Dec 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318134
Sponsor's protocol ID
Nanchanguniversity
Acronym
FMTP
Status last verified
Mar 2021
First submitted
12 Dec 2014
Last updated
14 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu H, Li W, Wang X, Li J, Yu W. Early gut mucosal dysfunction in patients with acute pancreatitis. Pancreas. 2008 Mar;36(2):192-6. doi: 10.1097/MPA.0b013e31815a399f.

    PubMed 18376312

  • Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

    PubMed 23100216

  • Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.

    PubMed 22310869

  • Landy J, Al-Hassi HO, McLaughlin SD, Walker AW, Ciclitira PJ, Nicholls RJ, Clark SK, Hart AL. Review article: faecal transplantation therapy for gastrointestinal disease. Aliment Pharmacol Ther. 2011 Aug;34(4):409-15. doi: 10.1111/j.1365-2036.2011.04737.x. Epub 2011 Jun 20.

    PubMed 21682755

  • Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.

    PubMed 24018052

  • Brandt LJ, Aroniadis OC. An overview of fecal microbiota transplantation: techniques, indications, and outcomes. Gastrointest Endosc. 2013 Aug;78(2):240-9. doi: 10.1016/j.gie.2013.03.1329. Epub 2013 May 2. No abstract available.

    PubMed 23642791

  • 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

  • Singh R, Nieuwdorp M, ten Berge IJ, Bemelman FJ, Geerlings SE. The potential beneficial role of faecal microbiota transplantation in diseases other than Clostridium difficile infection. Clin Microbiol Infect. 2014 Nov;20(11):1119-25. doi: 10.1111/1469-0691.12799. Epub 2014 Nov 7.

    PubMed 25274035

  • Allegretti JR, Hamilton MJ. Restoring the gut microbiome for the treatment of inflammatory bowel diseases. World J Gastroenterol. 2014 Apr 7;20(13):3468-74. doi: 10.3748/wjg.v20.i13.3468.

    PubMed 24707129

  • Shankar V, Hamilton MJ, Khoruts A, Kilburn A, Unno T, Paliy O, Sadowsky MJ. Species and genus level resolution analysis of gut microbiota in Clostridium difficile patients following fecal microbiota transplantation. Microbiome. 2014 Apr 21;2:13. doi: 10.1186/2049-2618-2-13. eCollection 2014.

    PubMed 24855561

  • 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

  • Ding L, He C, Li X, Huang X, Lei Y, Ke H, Chen H, Yang Q, Cai Y, Liao Y, He W, Xia L, Xiong H, Lu N, Zhu Y. Efficacy and Safety of Faecal Microbiota Transplantation for Acute Pancreatitis: A Randomised, Controlled Study. Front Med (Lausanne). 2022 Jan 10;8:772454. doi: 10.3389/fmed.2021.772454. eCollection 2021.

    PubMed 35083238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal Microbiota Transplantation and normal saline in people with Acute Pancreatitis and Intestinal Bacteria Flora Disturbance, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Apr 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Gastrointestinal Failure Score Equal 0 (time frame: one week after intervention). 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 NCT02318134, which also lists 12 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 14 Apr 2021.

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