Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

Sponsor

Nanfang Hospital, Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06134544

Collaborator

(none)

Enrollment

Arm

3.4

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Decompensated Cirrhosis	Dietary Supplement: Isomaltooligosaccharides (IMO)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Acutely decompensated cirrhosis ( with ascites).Acutely decompensated cirrhosis ( with ascites).

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Dec 10, 2023

Anticipated Study Completion Date :

Feb 20, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes of Lipopolysaccharide (LPS) in plasma [Before (Day-0) and after treatment (Day-8).]
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test

Secondary Outcome Measures

Changes of bacterial load in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
Count the Colony-Forming Units (CFU) to value the bacterial load
Changes of markers of infections (CRP) in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
C-reactive protein
Changes of markers of infections (PCT) in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
Procalcitonin，PCT
Changes of markers of kidney failure (Cr) in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
Creatinine，Cr
Changes of markers of coagulation failure (INR) in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
International normalized ratio，INR
Changes of markers of liver failure (TBIL) in plasma [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
Total bilirubin，TBIL
Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment [After 7-day non-treatment (day 15).]
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test
Incidence of bacterial infection [After treatment (Day-8) up to follow-up (Day-28)]
All kinds of infection, including pneumonia, SBP, urine tract infection and so on.
Development of acute-on-chronic liver failure [After treatment (Day-8) up to follow-up (Day-28)]
Diagnosis of ACLF is based on the criteria of EASL-ACLF.
Changes of Meld scores which evaluate severity of liver diseases. [Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).]
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).
28-day mortality [Day-28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital, Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital, Southern Medical University

ClinicalTrials.gov Identifier:

NCT06134544

Other Study ID Numbers:

NFEC-2023-457

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Cirrhosis

Fibrosis

Study Results

No Results Posted as of Nov 18, 2023