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Trial record 4 of 91 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation for Pancreatitis (FMTP)

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ClinicalTrials.gov Identifier: NCT02318134
Recruitment Status : Recruiting
First Posted : December 17, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Lingyu Luo, The First Affiliated Hospital of Nanchang University

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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Intestinal Bacteria Flora Disturbance Intestinal Dysfunction Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation Drug: The traditional treatment Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in SAP(Severe Acute Pancreatitis)Patients With Intestinal Barrier Dysfunction
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor,At the same time give patients the traditional treatment of SAP
Procedure: Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor
Other Names:
  • Fecal Microbiota Therapy
  • Fecal Transplantation

Drug: The traditional treatment
the traditional treatments according to associated guidelines
Other Name: Conventional drugs according to the guideline

The traditional treatment
The traditional treatment of SAP according to the associated guidelines
Drug: The traditional treatment
the traditional treatments according to associated guidelines
Other Name: Conventional drugs according to the guideline




Primary Outcome Measures :
  1. Gastrointestinal Failure score [ Time Frame: everyday after intervention for 7 days or 14 days ]
    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.


Secondary Outcome Measures :
  1. The incidence of infectious complications [ Time Frame: up to 12 weeks ]
    The incidence of infectious complications,such as pancreatic pseudocyst、walled-off necrosis、infected necrosis、Bacteraemia、Infected ascites.

  2. The incidence of organ failure [ Time Frame: up to 12 weeks ]
    The incidence of organ failure,such as acute respiratory failure,acute renal failure.

  3. interventions or surgery [ Time Frame: up to 12 weeks ]
    patients needs extra interventions or surgery

  4. Length of Intensive care time and hospital stay [ Time Frame: up to 12 weeks ]
    patients' Length of Intensive care time and hospital stay due to the disease

  5. Mortality [ Time Frame: up to 12 weeks ]
    patients who die due to the diseases

  6. the number of defecation [ Time Frame: up to 12 weeks ]
    the time to restore spontaneous defecation, after the daily number of defecation and defecation

  7. Diamine oxidase(DAO) [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    Plasma Diamine oxidase(DAO)level as a predictor in the diagnosis of Intestinal mucosal barrier injury

  8. D-lactate [ Time Frame: 1day before intervention,7days and 14days after intervention ]
    Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Onset of pancreatitis within <=2 weeks
  3. Gastrointestinal failure score (GIF score) >= 2 points. That is, food intolerance (due to high gastric retention, vomiting, flatulence or severe diarrhea) or intraperitoneal hypertension (≥ 12mmHg);

Exclusion Criteria:

  1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  2. Pregnancy and lactation women
  3. Not signed the informed consent
  4. Diabetes and autoimmune diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318134


Contacts
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Contact: Yin Zhu, MD 13970841464 zhuyin27@sina.com
Contact: Lingyu Luo, MD 15270855639 15270855639@163.com

Locations
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China, Jiangxi
the First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Nonghua Lv, MD    13707086809    lunonghua@163.com   
Contact: Kunhe Zhang, MD    13007202818    393467260@qq.com   
Principal Investigator: Nonghua Lv, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Nanchang University
Investigators
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Study Chair: Nonghua Lv, MD the Frist Affiliated Hospital of Nanchang University

Additional Information:
Publications:

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Responsible Party: Lingyu Luo, Physician-in-charge, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT02318134     History of Changes
Other Study ID Numbers: Nanchanguniversity
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lingyu Luo, The First Affiliated Hospital of Nanchang University:
Severe acute pancreatitis
Fecal Microbiota Transplantation
Intestinal barrier dysfunction
Intestinal flora
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases