RecruitingNot ApplicableNCT06134544

Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

18 participants

Start Date

Nov 25, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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

Exclusion Criteria14

  • 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

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Interventions

DIETARY_SUPPLEMENTIsomaltooligosaccharides (IMO)

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


Locations(1)

Nanfang Hospital

Guangzhou, Guangdong, China

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NCT06134544


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