Fecal Microbiota Transplantation in Cirrhosis

NCT04591522 | Unknown

• 1 other identifier: Yongping_Chen
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis, Liver

Keywords

Cirrhosis；fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (14)

• blood ammonia

  blood ammonia in umol/L

  Change from baseline blood ammonia at 12 months

• alanine aminotransferase

  alanine aminotransferase in U/L

  Change from baseline alanine aminotransferase at 12 months

• aspartate aminotransferase

  aspartate aminotransferase in U/L

  Change from baseline aspartate aminotransferase at 12 months

• gut microbiome

  16S RNA sequencing in gut microbiome

  Change from baseline gut microbiome at 12 months

• white blood cell

  white blood cell in /L

  Change from baseline white blood cell at 12 months

• hemoglobin

  hemoglobin in g/L

  Change from baseline hemoglobin at 12 months

• blood platelet

  blood platelet in/L

  Change from baseline blood platelet at 12 months

• albumin

  albumin in g/L

  Change from baseline albumin at 12 months

• blood glucose

  blood glucose in mmol/L

  Change from baseline blood glucose at 12 months

• Serum creatinine

  Serum creatinine in umol/L

  Change from baseline serum creatinine at 12 months

• direct bilirubin

  direct bilirubin in umol/L

  Change from baseline direct bilirubin at 12 months

• indirect bilirubin

  indirect bilirubin in umol/L

  Change from baseline indirect bilirubin at 12 months

• prothrombin time activity percentage

  prothrombin time activity percentage in %

  Change from baseline prothrombin time activity percentage at 12 months

• liver stiffness

  liver stiffness in Kpa

  Change from baseline liver stiffness at 12 months

Secondary Outcomes (1)

• Concentration of HIF-1α in intestine

  Change from baseline HIF-1α expression in intestine at 12 months

Study Arms (2)

FMT group

EXPERIMENTAL

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

control group

NO INTERVENTION

Interventions

Healthy fecal bacteria liquid OTHER

Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.

FMT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Related Publications (1)

• 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.

  PMID: 31004827 RESULT

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• yongping Chen, Prof

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongping Chen, Prof

CONTACT

+8613505777281; did@wzhospital.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: October 19, 2020
• Study Start: October 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share