Fecal Microbiota Transplantation for Pancreatitis

NCT02318134 | Completed Phase 2 Results

• 1 other identifier: Nanchanguniversity
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction; Fecal Microbiota Transplantation

Keywords

Severe acute pancreatitis; Fecal Microbiota Transplantation; Intestinal barrier dysfunction; Intestinal flora

Outcome Measures

Primary Outcomes (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.

  one week after intervention

Secondary Outcomes (7)

• Number of Participants With Infectious Complications

  120 days

• Number of Participants With Organ Failure

  120 days

• Number of Participants With Interventions or Surgery

  120 days

• Length of Intensive Care Time and Hospital Stay

  6 months

• Mortality

  120 days

Study Arms (2)

FMT group

EXPERIMENTAL

In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.

Procedure: Fecal Microbiota Transplantation

Control group

PLACEBO COMPARATOR

In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.

Drug: normal saline

Interventions

Fecal Microbiota Transplantation PROCEDURE

FMT via a nasoduodenal tube with fresh bacteria from healthy donor

Also known as: Fecal Microbiota Therapy, Fecal Transplantation

FMT group

normal saline DRUG

Normal saline via a nasoduodenal tube.

Also known as: normal saline 0.9%

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (12)

• 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.

  PMID: 18376312 BACKGROUND

• 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.

  PMID: 23100216 BACKGROUND

• 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.

  PMID: 22310869 BACKGROUND

• 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.

  PMID: 21682755 BACKGROUND

• 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.

  PMID: 24018052 BACKGROUND

• 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.

  PMID: 23642791 BACKGROUND

• 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.

  PMID: 24939885 BACKGROUND

• 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.

  PMID: 25274035 BACKGROUND

• 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.

  PMID: 24707129 BACKGROUND

• 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.

  PMID: 24855561 BACKGROUND

• 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.

  PMID: 23660099 BACKGROUND

• 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.

  PMID: 35083238 DERIVED

Related Links

• the First Affiliated Hospital of Nanchang University

MeSH Terms

Conditions

Pancreatitis

Interventions

Fecal Microbiota Transplantation; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Ling Ding
• Organization: First Affiliated Hospital of Nanchang University

2495802456@qq.com

15279196058

Study Officials

• Nonghua Lv, MD

  the Frist Affiliated Hospital of Nanchang University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 18, 2017
• Primary Completion: April 17, 2019
• Study Completion: December 18, 2019
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Locations

CN (1)