Fecal Microbiota Transplantation in Cirrhosis (FMT)

• ClinicalTrials.gov Identifier: NCT04591522
• Recruitment Status: Not yet recruiting
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Information provided by (Responsible Party): First Affiliated Hospital of Wenzhou Medical University

Study Description

Brief Summary:

Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.

Condition or disease	Intervention/treatment	Phase
Cirrhosis, Liver	Other: Healthy fecal bacteria liquid	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation
• Estimated Study Start Date: October 15, 2020
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: FMT group; Patients were carried by fecal microbiota transplantation which described in detail that fecal bacteria are extracted from the faeces of healthy people and poured into the intestines of patients.	Other: Healthy fecal bacteria liquid; Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.
No Intervention: control group

Outcome Measures

Primary Outcome Measures :

1. blood ammonia [ Time Frame: Change from baseline blood ammonia at 12 months ]
   blood ammonia in umol/L
2. alanine aminotransferase [ Time Frame: Change from baseline alanine aminotransferase at 12 months ]
   alanine aminotransferase in U/L
3. aspartate aminotransferase [ Time Frame: Change from baseline aspartate aminotransferase at 12 months ]
   aspartate aminotransferase in U/L
4. gut microbiome [ Time Frame: Change from baseline gut microbiome at 12 months ]
   16S RNA sequencing in gut microbiome
5. white blood cell [ Time Frame: Change from baseline white blood cell at 12 months ]
   white blood cell in /L
6. hemoglobin [ Time Frame: Change from baseline hemoglobin at 12 months ]
   hemoglobin in g/L
7. blood platelet [ Time Frame: Change from baseline blood platelet at 12 months ]
   blood platelet in/L
8. albumin [ Time Frame: Change from baseline albumin at 12 months ]
   albumin in g/L
9. blood glucose [ Time Frame: Change from baseline blood glucose at 12 months ]
   blood glucose in mmol/L
10. Serum creatinine [ Time Frame: Change from baseline serum creatinine at 12 months ]
    Serum creatinine in umol/L
11. direct bilirubin [ Time Frame: Change from baseline direct bilirubin at 12 months ]
    direct bilirubin in umol/L
12. indirect bilirubin [ Time Frame: Change from baseline indirect bilirubin at 12 months ]
    indirect bilirubin in umol/L
13. prothrombin time activity percentage [ Time Frame: Change from baseline prothrombin time activity percentage at 12 months ]
    prothrombin time activity percentage in %
14. liver stiffness [ Time Frame: Change from baseline liver stiffness at 12 months ]
    liver stiffness in Kpa

Secondary Outcome Measures :

1. Concentration of HIF-1α in intestine [ Time Frame: Change from baseline HIF-1α expression in intestine at 12 months ]
   Concentration of HIF-1α expression in intestine by western blot

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Clinical diagnosis of cirrhotic
• aged 18-80 years.
• must be able to cooperate with treatment

Exclusion Criteria:

• Patients with severe cardiac, pulmonary and renal dysfunction;
• Patients with severe hypertension and cerebrovascular accidents;
• Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding;
• Prothrombin activity ≤40%, platelet count < 50*10^9/L;
• Patients with intellectual and language disorders and mental disorders;
• Probiotics with antibiotic and drug grade were used within 3 months prior to sampling;
• There are prehepatic or posthepatic portal hypertension reasons;
• Drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (IFN) treatment;
• Peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc.
• Other researchers believe that patients should not be included in the group.

Contacts and Locations

Contacts

Contact: Yongping Chen, Prof; +8613505777281; did@wzhospital.cn

Sponsors and Collaborators

First Affiliated Hospital of Wenzhou Medical University

Investigators

• Principal Investigator: yongping Chen, Prof; First Affiliated Hospital of Wenzhou Medical University

More Information

Publications of Results:

Sung CM, Lin YF, Chen KF, Ke HM, Huang HY, Gong YN, Tsai WS, You JF, Lu MJ, Cheng HT, Lin CY, Kuo CJ, Tsai IJ, Hsieh SY. Predicting Clinical Outcomes of Cirrhosis Patients With Hepatic Encephalopathy From the Fecal Microbiome. Cell Mol Gastroenterol Hepatol. 2019;8(2):301-318.e2. doi: 10.1016/j.jcmgh.2019.04.008. Epub 2019 Apr 18.

• Responsible Party: First Affiliated Hospital of Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT04591522
• Other Study ID Numbers: Yongping_Chen
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Wenzhou Medical University:

Cirrhosis；fecal Microbiota Transplantation

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases