Investigating the effects of isomaltooligosaccharides on gut bacteria in liver cirrhosis patients
Effect of Isomaltooligosaccharides on Intestinal Bacterial Translocation in Patients With Liver Cirrhosis: a Single-center, Single-arm Study
This study is testing if a type of fiber called isomaltooligosaccharides can help improve gut health in patients with liver cirrhosis by looking at changes in certain bacteria levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06134544 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the protective effects of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients suffering from decompensated cirrhosis. The primary focus is to assess changes in lipopolysaccharides (LPS) levels following the administration of IMO. By understanding how IMO influences gut microbiota and its translocation, the study seeks to provide insights into potential therapeutic strategies for managing complications associated with liver cirrhosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with decompensated cirrhosis and elevated LPS levels.
Not a fit: Patients with active infections, severe comorbidities, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve gut health and reduce complications in patients with liver cirrhosis.
How similar studies have performed: While the specific use of IMO in this context may be novel, similar studies have explored gut microbiota modulation in liver disease with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jinjun Chen, PhD
- Email: chjj@smu.edu.cn
- Phone: 44-13902246336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.