Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

Decompensated Cirrhosis Clinical Trial

Official title:

Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134544
• Other study ID #: NFEC-2023-457
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Jinjun Chen, PhD
• Phone: 44-13902246336
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients with liver cirrhosis. The main question is to answer the changes of LPS after adminstration of IMO.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age from 18-75.

• Cirrhotic patients.

• Decompensation event: ascites.

• LPS>0.45EU/ml.

Exclusion Criteria:

• Pregnant or breast-feeding.

• Active bacterial or fungal infection.

• Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage.

• Diagnosis of EASL-ACLF.

• Diarrhea.

• Malignancy.

• Anticipated short survival time.

• Adverse reactions or allergies to oral carbohydrate preparations.

• Substance abuse or addiction.

• Severe extrahepatic diseases (e.g. patients with CKD-5 stage, severe cardiopulmonary dysfunction, and psychiatric disorders).

• Be immunosuppressed or immunodeficient states and the use of immunoglobulins or other immune-boosting conditions.

• Be unsuitable for participating in this trial.

• Participated in any drug trial within the past month

• History of antibacterial or fungal use within 1 week prior to screening

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Dietary Supplement:
• Isomaltooligosaccharides (IMO)
Patients will still receive standard treatment, including medicine and other invasive treatment.

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Lipopolysaccharide (LPS) in plasma	LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test	Before (Day-0) and after treatment (Day-8).
Secondary	Changes of bacterial load in plasma	Count the Colony-Forming Units (CFU) to value the bacterial load	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of markers of infections (CRP) in plasma	C-reactive protein	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of markers of infections (PCT) in plasma	Procalcitonin,PCT	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of markers of kidney failure (Cr) in plasma	Creatinine,Cr	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of markers of coagulation failure (INR) in plasma	International normalized ratio,INR	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of markers of liver failure (TBIL) in plasma	Total bilirubin,TBIL	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment	LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test	After 7-day non-treatment (day 15).
Secondary	Incidence of bacterial infection	All kinds of infection, including pneumonia, SBP, urine tract infection and so on.	After treatment (Day-8) up to follow-up (Day-28)
Secondary	Development of acute-on-chronic liver failure	Diagnosis of ACLF is based on the criteria of EASL-ACLF.	After treatment (Day-8) up to follow-up (Day-28)
Secondary	Changes of Meld scores which evaluate severity of liver diseases.	Model for End-Stage Liver Disease (MELD) is used to estimates a patient's chances of surviving their disease during the next three months. This numerical scale is used for adult patients waiting for a transplant. The MELD score ranges from 6 to 40 (gravely ill). The individual score tells you what is the urgency of undergoing a liver transplant during the next 90 days (three months).	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Secondary	28-day mortality		Day-28