Fecal Microbiota Transplantation for Decompensated Cirrhosis

Fecal Microbiota Transplantation Clinical Trial

— FMTDC  

Official title:

Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014505
• Other study ID #: FMT-GYH
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2017
• Last updated: January 6, 2017
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Yan Zhou, Ph.D
• Phone: +86-18981941992
• Email: zqlvzy319[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fecal Microbiota Transplantation
• Fibrosis
• Liver Cirrhosis

Intervention

Biological:
• FMT
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1

Other:
• traditional treatments
traditional treatments for Decompensated Cirrhosis in part 2

Locations

Country	Name	City	State
China	IEC of Chengdu Medical College	Chendu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in liver function test as compared to baseline in both groups.		3 months	No
Secondary	Reduction in systemic inflammatory markers like TNF-a in both groups.		3 months	No
Secondary	Reduction in systemic inflammatory markers like IL-6 in both groups.	Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.	3 months	No
Secondary	Reduction in systemic inflammatory markers like serum endotoxins in both groups.		3 months	No
Secondary	Diamine oxidase(DAO)		3 months	No
Secondary	Histological changes in the intestinal biopsy in both groups.		3 months	No
Secondary	Microbiota composition	Deep sequencing of the microbiota at baseline and post-FMT.	3 months	No