NCT03014505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

January 3, 2017

Last Update Submit

January 6, 2017

Conditions

Decompensated CirrhosisFecal Microbiota Transplantation

Keywords

CirrhosisFecal Microbiota TransplantationIntestinal floraIntestinal mucosal barrierIntestinal Bacteria Flora Disturbance

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events complication rate in all patients in both groups

    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.

    3 months

Secondary Outcomes (7)

  • Improvement in liver function test as compared to baseline in both groups.

    3 months

  • Reduction in systemic inflammatory markers like TNF-α in both groups.

    3 months

  • Reduction in systemic inflammatory markers like IL-6 in both groups.

    3 months

  • Reduction in systemic inflammatory markers like serum endotoxins in both groups.

    3 months

  • Diamine oxidase（DAO）

    3 months

  • +2 more secondary outcomes

Study Arms (2)

FMT

EXPERIMENTAL

Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments

Biological: FMT

The traditional treatments

ACTIVE COMPARATOR
Other: traditional treatments

Interventions

FMTBIOLOGICAL

Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1

Also known as: Fecal Microbiota Transplantation
FMT
traditional treatmentsOTHER

traditional treatments for Decompensated Cirrhosis in part 2

The traditional treatments

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Ongoing bacterial infection requiring antibiotic treatment.
  • 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).
  • consecutive months within 1 year prior to screening.
  • Treatment with antibiotics or probiotics in the preceding 3 months.
  • Inability to safely perform an GastroIntestinal endoscopy.
  • No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).
  • Human Immunodeficiency Virus (HIV) infection.
  • Active, serious medical disease with likely life expectancy less than 5 years.
  • Active substance abuse including inhaled or injection drugs in the year prior to screening.
  • pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.
  • Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
  • History of severe (anaphylactic) food allergy.
  • History of gastroparesis or altered gastric motility -
  • Psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IEC of Chengdu Medical College

Chendu, 610500, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Xiao-an Li, Ph.D

    First Affiliated Hospital of Chengdu Medical College

    STUDY CHAIR

Central Study Contacts

Yan Zhou, Ph.D

CONTACT

+86-18981941992zqlvzy319@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 9, 2017

Study Start

August 1, 2016

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)