Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Decompensated Cirrhosis
• Intervention / Treatment: Dietary supplement: Isomaltooligosaccharides (IMO)

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinjun Chen, PhD; Phone Number: 44-13902246336; Email: chjj@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital
      • Contact: CHEN Jinjun; Phone Number: +86 020 62787310; Email: chjj@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of IMO; Patients will be given IMO (20g/100ml) for 7 days.	Dietary supplement: Isomaltooligosaccharides (IMO); Patients will still receive standard treatment, including medicine and other invasive treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
Changes of markers of infections (PCT) in plasma	Procalcitonin，PCT	Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
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).
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).
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).
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).
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)
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)
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).
28-day mortality		Day-28

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: NFEC-2023-457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No