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Fecal Microbiota Transplantation for Decompensated Cirrhosis (FMTDC)

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ClinicalTrials.gov Identifier: NCT03014505
Recruitment Status : Unknown
Verified January 2017 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Chengdu Medical College

Brief Summary:
Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Fecal Microbiota Transplantation Biological: FMT Other: traditional treatments Phase 1 Phase 2

Detailed Description:
Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FMT
Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments
Biological: FMT
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
Other Name: Fecal Microbiota Transplantation

Active Comparator: The traditional treatments Other: traditional treatments
traditional treatments for Decompensated Cirrhosis in part 2




Primary Outcome Measures :
  1. Number of adverse events complication rate in all patients in both groups [ Time Frame: 3 months ]
    Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.


Secondary Outcome Measures :
  1. Improvement in liver function test as compared to baseline in both groups. [ Time Frame: 3 months ]
  2. Reduction in systemic inflammatory markers like TNF-α in both groups. [ Time Frame: 3 months ]
  3. Reduction in systemic inflammatory markers like IL-6 in both groups. [ Time Frame: 3 months ]
    Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.

  4. Reduction in systemic inflammatory markers like serum endotoxins in both groups. [ Time Frame: 3 months ]
  5. Diamine oxidase(DAO) [ Time Frame: 3 months ]
  6. Histological changes in the intestinal biopsy in both groups. [ Time Frame: 3 months ]
  7. Microbiota composition [ Time Frame: 3 months ]
    Deep sequencing of the microbiota at baseline and post-FMT.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >18 years of age
  2. Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.
  3. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.

Exclusion Criteria:

  1. Ongoing bacterial infection requiring antibiotic treatment.
  2. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).
  3. consecutive months within 1 year prior to screening.
  4. Treatment with antibiotics or probiotics in the preceding 3 months.
  5. Inability to safely perform an GastroIntestinal endoscopy.
  6. No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).
  7. Human Immunodeficiency Virus (HIV) infection.
  8. Active, serious medical disease with likely life expectancy less than 5 years.
  9. Active substance abuse including inhaled or injection drugs in the year prior to screening.
  10. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.
  11. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
  12. History of severe (anaphylactic) food allergy.
  13. History of gastroparesis or altered gastric motility -
  14. Psychiatric disorder

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): NCT03014505


Contacts
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Contact: Yan Zhou, Ph.D +86-18981941992 zqlvzy319@163.com

Locations
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China
IEC of Chengdu Medical College Recruiting
Chendu, China, 610500
Contact: Xiao-an Li, doctor    +8613680868858    zqzy1983@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chengdu Medical College
Investigators
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Study Chair: Xiao-an Li, Ph.D First Affiliated Hospital of Chengdu Medical College

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Responsible Party: First Affiliated Hospital of Chengdu Medical College
ClinicalTrials.gov Identifier: NCT03014505     History of Changes
Other Study ID Numbers: FMT-GYH
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by First Affiliated Hospital of Chengdu Medical College:
Cirrhosis
Fecal Microbiota Transplantation
Intestinal flora
Intestinal mucosal barrier
Intestinal Bacteria Flora Disturbance
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases