Swallowable capsule could unlock secrets of Gut-Liver connection
NCT ID NCT06708832
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special capsule, called SIMBA, can safely collect fluid from the small intestine in people with liver cirrhosis. Participants swallow two capsules, which are later recovered from stool. Researchers will analyze the fluid to compare gut bacteria and metabolites with those found in mouth and stool samples. The goal is to see if this method works and could help understand how the small intestine microbiome relates to liver disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SIMBA capsule (Small Intestine Microbiome Aspiration capsule)
- What this could lead to
- If successful, this method could help researchers better understand how gut bacteria in the small intestine affect liver disease, potentially pointing toward new treatments.
- What could go wrong
- This is a very small pilot study with only 11 participants, focused on feasibility. The capsule may not always collect enough fluid, and results may not apply to all cirrhosis patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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11 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic
Graz, 8010, Austria
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