Fecal Microbiota Transplantation in Cirrhosis

NCT ID: NCT04591522

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy fecal bacteria liquid

Intervention Type: OTHER

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

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy fecal bacteria liquid

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yongping Chen, Prof

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Central Contacts

Yongping Chen, Prof

Role: CONTACT

did@wzhospital.cn

+8613505777281

References

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.

Reference Type: RESULT

PMID: 31004827 (View on PubMed)

Other Identifiers

Yongping_Chen

Identifier Type: -

Identifier Source: org_study_id