Clinical trial NCT04591522: Fecal Microbiota Transplantation in Cirrhosis
Official title: The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: Cirrhosis；fecal Microbiota Transplantation
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: blood ammonia
timeFrame: Change from baseline blood ammonia at 12 months
measure: alanine aminotransferase
timeFrame: Change from baseline alanine aminotransferase at 12 months
measure: aspartate aminotransferase
timeFrame: Change from baseline aspartate aminotransferase at 12 months
measure: gut microbiome
timeFrame: Change from baseline gut microbiome at 12 months
measure: white blood cell
timeFrame: Change from baseline white blood cell at 12 months
measure: hemoglobin
timeFrame: Change from baseline hemoglobin at 12 months
measure: blood platelet
timeFrame: Change from baseline blood platelet at 12 months
measure: albumin
timeFrame: Change from baseline albumin at 12 months
measure: blood glucose
timeFrame: Change from baseline blood glucose at 12 months
measure: Serum creatinine
timeFrame: Change from baseline serum creatinine at 12 months
measure: direct bilirubin
timeFrame: Change from baseline direct bilirubin at 12 months
measure: indirect bilirubin
timeFrame: Change from baseline indirect bilirubin at 12 months
measure: prothrombin time activity percentage
timeFrame: Change from baseline prothrombin time activity percentage at 12 months
measure: liver stiffness
timeFrame: Change from baseline liver stiffness at 12 months
Secondary outcomes:
measure: Concentration of HIF-1α in intestine
timeFrame: Change from baseline HIF-1α expression in intestine at 12 months
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: yongping Chen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.