To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules

Launched by MEDICAL UNIVERSITY OF GRAZ · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to collect information about the small intestine in patients who have liver cirrhosis, a serious condition that affects the liver. The researchers will use a special capsule called SIMBA (Small Intestinal MicroBiome Aspiration) to see if it is possible to gather data about the bacteria and substances in the small intestine. They will compare this data with information collected from other sources, such as saliva and stool samples, to better understand the differences and similarities in gut health.

To participate in this study, you need to be at least 18 years old and have a diagnosis of liver cirrhosis confirmed by a doctor. You must also be able to swallow a capsule that is about the size of a large vitamin. However, there are some reasons you may not be eligible, such as having certain gastrointestinal conditions or surgeries in the past. If you join the study, you will swallow the SIMBA capsule, and researchers will monitor your health throughout the process. It's important to note that the study is not yet recruiting participants, so if you're interested, you will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age above 18 years
• • Written informed consent
• • Liver cirrhosis diagnosis by clinical/radiological/histological features
• • Able to swallow a size-00 capsule (23mm length and 8mm width)
• Exclusion Criteria:
• • Inability to give informed consent
• • Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
• • History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
• • Known history abdominal radiation treatment.
• • Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 h before swallowing SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
• • Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• • Any significant heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
• • History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
• • Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
• • Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
• • Any prior Fecal Microbiota Transplantation.
• • Colon cleanses/bowel prep for 2 weeks
• • Pregnant or breastfeeding.
• • Planning to become pregnant.
• • Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.
• • History of less than three (3) bowel movements per week.