Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

NCT06134544 | Recruiting

• 1 other identifier: NFEC-2023-457
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes of bacterial load in plasma

  Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).

• Changes of markers of infections (CRP) in plasma

  Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).

• Changes of markers of infections (PCT) in plasma

  Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).

• Changes of markers of kidney failure (Cr) in plasma

  Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).

• Changes of markers of coagulation failure (INR) in plasma

  Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).

Study Arms (1)

Administration of IMO

EXPERIMENTAL

Patients will be given IMO (20g/100ml) for 7 days.

Dietary Supplement: Isomaltooligosaccharides (IMO)

Interventions

Isomaltooligosaccharides (IMO) DIETARY_SUPPLEMENT

Patients will still receive standard treatment, including medicine and other invasive treatment.

Administration of IMO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18-75.
• Cirrhotic patients.
• Decompensation event: ascites.
• LPS\>0.45EU/ml.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Jinjun Chen, PhD

CONTACT

44-13902246336; chjj@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Acutely decompensated cirrhosis ( with ascites).

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: November 25, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)