Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

NCT ID: NCT06134544

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Decompensated Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Acutely decompensated cirrhosis ( with ascites).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Administration of IMO

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

Group Type EXPERIMENTAL

Isomaltooligosaccharides (IMO)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Isomaltooligosaccharides (IMO)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinjun Chen, PhD

Role: CONTACT

44-13902246336

Facility Contacts

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CHEN Jinjun

Role: primary

+86 020 62787310

Other Identifiers

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NFEC-2023-457

Identifier Type: -

Identifier Source: org_study_id

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