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Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

N

Nanfang Hospital, Southern Medical University

Status

Enrolling

Conditions

Decompensated Cirrhosis

Treatments

Dietary Supplement: Isomaltooligosaccharides (IMO)

Study type

Interventional

Funder types

Other

Identifiers

NCT06134544
NFEC-2023-457

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Administration of IMO
Experimental group
Description:
Patients will be given IMO (20g/100ml) for 7 days.
Treatment:
Dietary Supplement: Isomaltooligosaccharides (IMO)

Trial contacts and locations

1

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Central trial contact

Jinjun Chen, PhD

Data sourced from clinicaltrials.gov

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