Ongoing Clinical Trials for Hepatobiliary Disease
Currently, there is 1 ongoing clinical trial focused on hepatobiliary disease, specifically targeting patients with liver cirrhosis and ascites. This trial is investigating a novel treatment approach using fecal microbiota transfer capsules to reduce immune system activation in patients with advanced liver disease.
Clinical trial locations
- Germany
Study on Intestifix for Treating Immune Activation in Patients with Liver Cirrhosis and Ascites
This clinical trial is investigating a new treatment approach for patients with cirrhosis and ascites. Cirrhosis occurs when the liver becomes severely scarred and loses its ability to function properly. Ascites refers to the buildup of fluid in the abdomen, which commonly occurs in people with advanced liver disease. The trial is testing whether a treatment called INTESTIFIX 001 can help reduce inflammation and improve the condition of these patients.
Who can participate:
- Adults between 18 and 70 years old
- People with confirmed cirrhosis from any cause, verified through medical tests, imaging scans, or liver biopsy
- Patients who have ascites and have undergone a procedure to remove or test the fluid within the last 30 days
- Individuals who are able to swallow capsules
- Patients who are mentally and physically capable of understanding the study requirements and following the protocol
- Those willing to provide written informed consent
Who cannot participate:
- Patients with medical conditions other than cirrhosis and ascites
- Individuals outside the specified age range
- Those who do not meet the specific characteristics the study is focusing on
What the trial involves:
The investigational treatment is INTESTIFIX 001, which consists of capsules containing fecal microbiota transfer (FMT). This means the capsules contain beneficial bacteria from healthy stool that are transferred into the patient’s gut. The idea behind this approach is that introducing these healthy bacteria may help balance the gut microbiome and reduce immune system overactivation, which is a significant problem in people with liver disease.
The study is designed as a placebo-controlled trial, meaning some participants will receive the active treatment while others will receive capsules without active medication. This allows researchers to compare the effects and determine whether the treatment provides real benefits. Participants will take the capsules orally over a period of approximately three months.
Study timeline:
Upon enrollment, participants undergo an initial assessment to establish baseline health measurements. This includes checking inflammation markers in the blood (such as white blood cell count and C-reactive protein) and in the gut (such as fecal calprotectin). Liver function scores (Child-Pugh score and MELD score) and quality of life measurements (EQ-5D-5L) are also recorded.
After receiving the capsules, participants attend follow-up visits on day 7, day 28, and day 90. During these visits, the same assessments are repeated to track any changes in inflammation levels, liver function, and quality of life. Researchers carefully monitor and record any side effects or adverse events throughout the study period.
Study goals:
The primary focus of this trial is to evaluate the safety of FMT capsules in treating immune activation in patients with cirrhosis and ascites. The researchers are particularly interested in monitoring for any serious adverse events. Secondary goals include measuring whether the treatment can reduce inflammation markers, improve liver function scores, and enhance quality of life for participants.
This is a phase IIa pilot study, which means it represents an early stage of testing to gather initial safety and effectiveness data. The findings from this trial will help determine whether larger studies are warranted to further investigate this treatment approach.
Summary
Currently, there is one active clinical trial focused on hepatobiliary disease, specifically targeting patients with liver cirrhosis and ascites. This trial is being conducted in Germany and represents an innovative approach to treating liver disease complications by targeting the gut microbiome. The study is investigating INTESTIFIX 001, a fecal microbiota transfer treatment delivered in capsule form, which aims to reduce immune system activation in patients with advanced liver disease.
The trial is particularly notable for its focus on the connection between gut bacteria and liver disease progression. By attempting to restore a healthy balance of gut bacteria, researchers hope to address the immune system dysfunction that contributes to complications in cirrhosis patients. The study will provide important safety data and preliminary effectiveness information that could guide future research in this area.
Patients with cirrhosis and ascites who are interested in participating should be aware that this is an early-phase study primarily focused on safety assessment. The trial requires a commitment to regular follow-up visits over a three-month period and the ability to swallow capsules. As with all clinical trials, participation offers the opportunity to access experimental treatments while contributing to medical knowledge that may benefit future patients with similar conditions.