Clinical trial NCT06134544: Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis
Official title: Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decompensated Cirrhosis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Acutely decompensated cirrhosis ( with ascites).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of Lipopolysaccharide (LPS) in plasma
timeFrame: Before (Day-0) and after treatment (Day-8).
Secondary outcomes:
measure: Changes of bacterial load in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of markers of infections (CRP) in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of markers of infections (PCT) in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of markers of kidney failure (Cr) in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of markers of coagulation failure (INR) in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of markers of liver failure (TBIL) in plasma
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment
timeFrame: After 7-day non-treatment (day 15).
measure: Incidence of bacterial infection
timeFrame: After treatment (Day-8) up to follow-up (Day-28)
measure: Development of acute-on-chronic liver failure
timeFrame: After treatment (Day-8) up to follow-up (Day-28)
measure: Changes of Meld scores which evaluate severity of liver diseases.
timeFrame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
measure: 28-day mortality
timeFrame: Day-28
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: