Decompensated CirrhosisNCT06134544
Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis
A study testing Isomaltooligosaccharides (IMO) in people with Decompensated Cirrhosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Isomaltooligosaccharides (IMO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18-75.
- Cirrhotic patients.
- Decompensation event: ascites.
- LPS>0.45EU/ml.
Who cannot join
- Pregnant or breast-feeding.
- Active bacterial or fungal infection.
- Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage.
- Diagnosis of EASL-ACLF.
- Diarrhea.
- Malignancy.
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
CHEN Jinjun, +86 020 62787310, chjj@smu.edu.cn
About this study
Official title: Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study
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
- Being tested
- Isomaltooligosaccharides (IMO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isomaltooligosaccharides (IMO)Dietary supplement
Patients will still receive standard treatment, including medicine and other invasive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Administration of IMO | Experimental | Patients will be given IMO (20g/100ml) for 7 days. Receives: Dietary Supplement: Isomaltooligosaccharides (IMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Lipopolysaccharide (LPS) in plasma
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test
Measured: Before (Day-0) and after treatment (Day-8).
Secondary outcomes (11)
Changes of bacterial load in plasma
Count the Colony-Forming Units (CFU) to value the bacterial load
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of infections (CRP) in plasma
C-reactive protein
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of infections (PCT) in plasma
Procalcitonin，PCT
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of kidney failure (Cr) in plasma
Creatinine，Cr
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of coagulation failure (INR) in plasma
International normalized ratio，INR
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of liver failure (TBIL) in plasma
Total bilirubin，TBIL
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test
Measured: After 7-day non-treatment (day 15).
Incidence of bacterial infection
All kinds of infection, including pneumonia, SBP, urine tract infection and so on.
Measured: After treatment (Day-8) up to follow-up (Day-28)
Development of acute-on-chronic liver failure
Diagnosis of ACLF is based on the criteria of EASL-ACLF.
Measured: After treatment (Day-8) up to follow-up (Day-28)
Changes of Meld scores which evaluate severity of liver diseases.
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).
Measured: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
28-day mortality
Measured: Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start25 Nov 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Acutely decompensated cirrhosis ( with ascites).
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134544
- Sponsor's protocol ID
- NFEC-2023-457
- Status last verified
- Apr 2024
- First submitted
- 2 Nov 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study
- ClinicalTrials.gov ID
- NCT06134544
- Acronym / sponsor ID
- NFEC-2023-457
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Acutely decompensated cirrhosis ( with ascites).
| Arm | Type | Receives |
|---|---|---|
| Administration of IMO | Experimental | Dietary Supplement: Isomaltooligosaccharides (IMO)Patients will be given IMO (20g/100ml) for 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18-75.
- Cirrhotic patients.
- Decompensation event: ascites.
- LPS>0.45EU/ml.
Key exclusion criteria (14 listed)
- Pregnant or breast-feeding.
- Active bacterial or fungal infection.
- Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage.
- Diagnosis of EASL-ACLF.
- Diarrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isomaltooligosaccharides (IMO)Patients will still receive standard treatment, including medicine and other invasive treatment. | Dietary supplement | Administration of IMO |
Primary outcome
Changes of Lipopolysaccharide (LPS) in plasma
Time frame: Before (Day-0) and after treatment (Day-8).
LPS will be tested by Tachypiens Amebocyte Lysate (TAL) test
11 secondary outcomes
Changes of bacterial load in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of infections (CRP) in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of infections (PCT) in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of kidney failure (Cr) in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of coagulation failure (INR) in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of markers of liver failure (TBIL) in plasma
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
Changes of Lipopolysaccharide (LPS) in plasma after 7-day non-treatment
Time frame: After 7-day non-treatment (day 15).
Incidence of bacterial infection
Time frame: After treatment (Day-8) up to follow-up (Day-28)
Development of acute-on-chronic liver failure
Time frame: After treatment (Day-8) up to follow-up (Day-28)
Changes of Meld scores which evaluate severity of liver diseases.
Time frame: Before (Day-0) ,after treatment (Day-8), after 7-day non-treatment (day 15).
28-day mortality
Time frame: Day-28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltooligosaccharides (IMO) in people with Decompensated Cirrhosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinjun Chen, PhD (44-13902246336, chjj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Lipopolysaccharide (LPS) in plasma (time frame: Before (Day-0) and after treatment (Day-8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.