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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT group | Experimental | In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. |
|
| Control group | Placebo Comparator | In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Procedure | FMT via a nasoduodenal tube with fresh bacteria from healthy donor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infectious Complications | The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection. | 120 days |
| Number of Participants With Organ Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nonghua Lv, MD | the Frist Affiliated Hospital of Nanchang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18376312 | Background | 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. | |
| 23100216 | 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. |
| Label | URL |
|---|---|
| the First Affiliated Hospital of Nanchang University | View source |
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Participants were recruited between November 2017 and April 2019 from the intensive unit care, Department of Gastroenterology, First Affiliated Hospital of Nanchang University.
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| ID | Title | Description |
|---|---|---|
| FG000 | FMT Group | In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. |
| FG001 | Control Group | In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMT Group | In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. |
| BG001 | Control Group | In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | one week after intervention |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMT Group | In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infected pancreatic necrosis | Infections and infestations | Non-systematic Assessment | Positive culture of peripancreatic fluid or pancreatic necrosis obtained by either fine-needle aspiration or during the first percutaneous or endoscopic drainage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infected ascites | Infections and infestations | Non-systematic Assessment | bacteria or fungi detected in aspirate of intraperitoneal fluid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ling Ding | First Affiliated Hospital of Nanchang University | 15279196058 | 2495802456@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2017 | Mar 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| normal saline | Drug | Normal saline via a nasoduodenal tube. |
|
|
The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure. |
| 120 days |
| Number of Participants With Interventions or Surgery | number of patients who need extra interventions or surgery | 120 days |
| Length of Intensive Care Time and Hospital Stay | patients' Length of Intensive care time and hospital stay due to the disease | 6 months |
| Mortality | patients who die due to the diseases | 120 days |
| 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) | one week after intervention |
| 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). | one week after intervention |
| 22310869 | 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. |
| 21682755 | 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. |
| 24018052 | 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. |
| 23642791 | 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. |
| 24939885 | 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. |
| 25274035 | 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. |
| 24707129 | 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. |
| 24855561 | 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. |
| 23660099 | 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. |
| 35083238 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Causes of pancreatitis | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Drinker | Count of Participants | Participants |
|
| Iintra-abdominal pressure | Mean | Standard Deviation | mmHg |
|
| Time from first symptoms to admission | Median | Full Range | days |
|
| Time from admission to intervention | Median | Full Range | days |
|
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
|
| Secondary | Number of Participants With Infectious Complications | The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection. | Posted | Count of Participants | Participants | 120 days |
|
|
|
| Secondary | Number of Participants With Organ Failure | The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure. | Posted | Count of Participants | Participants | 120 days |
|
|
|
| Secondary | Number of Participants With Interventions or Surgery | number of patients who need extra interventions or surgery | Posted | Count of Participants | Participants | 120 days |
|
|
|
| Secondary | Length of Intensive Care Time and Hospital Stay | patients' Length of Intensive care time and hospital stay due to the disease | Posted | Median | Full Range | days | 6 months |
|
|
|
| Secondary | Mortality | patients who die due to the diseases | Posted | Count of Participants | Participants | 120 days |
|
|
|
| Secondary | 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) | Posted | Median | Full Range | percent change of DAO | one week after intervention |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | percent change of D-lactate | one week after intervention |
|
|
|
| 3 |
| 30 |
| 24 |
| 30 |
| 25 |
| 30 |
| EG001 | Control Group | In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube. | 4 | 30 | 24 | 30 | 25 | 30 |
|
| Persistent respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | PaO2/FiO2 below 300 |
|
| Persistent renal failure | Renal and urinary disorders | Non-systematic Assessment | Serum Creatinine over 170 μmol/l or 1.9 mg/dl |
|
| Persistent circulatory failure | Cardiac disorders | Non-systematic Assessment | Systolic blood pressure below 90 mm Hg, not fluid responsive or pH below 7.3 |
|
| gastrointestinal fistula | Gastrointestinal disorders | Non-systematic Assessment |
|
| intra-abdominal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastrointestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Bacteraemia | Infections and infestations | Non-systematic Assessment | positive blood culture |
|
| pneumonia | Infections and infestations | Non-systematic Assessment | Positive sputum or endotracheal culture |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | Positive urine culture |
|
| bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |
| Suspected or documented IPN |
|
| infected ascites |
|
| bacteremia |
|
| pneumonia |
|
| Urinary tract infection |
|
| Persistent renal failure |
|
| Persistent circulatory failure |
|
| Open surgery |
|
| Mechanical ventilation |
|
| Renal replacement therapy |
|