Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis
- Conditions
- Decompensated Cirrhosis
- Interventions
- Dietary Supplement: Isomaltooligosaccharides (IMO)
- Registration Number
- NCT06134544
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Age from 18-75.
- Cirrhotic patients.
- Decompensation event: ascites.
- LPS>0.45EU/ml.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of IMO Isomaltooligosaccharides (IMO) Patients will be given IMO (20g/100ml) for 7 days.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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
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).
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.
28-day mortality Day-28
Trial Locations
- Locations (1)
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China