Liver CirrhosisCAPNCT06708832
To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules
A study testing SIMBA ingestion in people with Liver Cirrhosis, run by Vanessa Stadlbauer-Koellner, MD at 1 site in Austria.
Trial summary
In this study, the feasibility to use SIMBA (Small Intestinal MicroBiome Aspiration) capsules to collect small intestinal microbiome and metabolome information will be evaluated in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- SIMBA ingestion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jun 2025to 16 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic
Graz, 8010
About this study
Official title: Pilot Study to Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules
In this study, the feasibility to use SIMBA (Small Intestinal MicroBiome Aspiration) capsules to collect small intestinal microbiome and metabolome information will be evaluated in patients with liver cirrhosis. Furthermore, the comparability oral, fecal and small intestinal microbiome and metabolome composition based on similarities and differences in 16s sequencing data and NMR metabolomics data will be evaluated.
- Conditions
- Liver Cirrhosis
- Being tested
- SIMBA ingestion
- Keywords
- Microbiome, Metabolome, 16s rRNA, NMR, Pilot study, Duodenal microbiome, Liver Cirrhosis, SIMBA, Capsule, Metabolomics
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMBA ingestionDevice
Also called Small Intestine Microbiome Aspiration Capsules
Ingestion of 2 SIMBA capsules at the same time and their excretion.
| Study group | Role | What they receive |
|---|---|---|
| SIMBA ingestion | Experimental | Participants will be prescreened for eligibility prior to obtaining informed consent. After informed consent is signed the participant will be screened and requested to complete a set of questionnaires prior to the ingestion of the SIMBA capsules. Then, a saliva and fecal sample will be collected and SIMBA capsules are ingested. The participant will be instructed on capsule ingestion. Retrieval of capsules occurs in their home environment. The participant is expected to continue searching their stool until both capsules are found. A fecal sample will be collected upon retrieval of first SIMBA capsule. After both capsules are collected the participants schedules an appointment to deliver the capsules to the study center and complete the second set of questionnaires. Additionally, saliva sample will be collected again. Receives: Device: SIMBA ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of capsules successfully recovered
Number of capsules successfully recovered with sufficient amount of fluid collected for the analysis (absolute number, percentage)
Measured: From ingestion of capsules to their excretion
Secondary outcomes (7)
Composition of the microbiome in capsule fluid (16s rRNA)
Composition of the microbiome in capsule fluid measured by 16s rRNA sequencing
Measured: From ingestion of capsules to their excretion
Composition of the microbiome in stool (16s rRNA)
Composition of the microbiome in stool microbiome measured by 16s rRNA sequencing
Measured: From ingestion of capsules to their excretion
Composition of the microbiome in saliva (16s rRNA)
Composition of the microbiome in saliva microbiome measured by 16s rRNA sequencing
Measured: From ingestion of capsules to their excretion
Composition of the metabolome in capsule fluid (NMR)
Composition of the metabolome in capsule fluid measured by NMR metabolomics
Measured: From ingestion of capsules to their excretion
Composition of the metabolome in saliva (NMR)
Composition of the metabolome in saliva measured by NMR metabolomics
Measured: From ingestion of capsules to their excretion
Composition of the metabolome in stool (NMR)
Composition of the metabolome in stool measured by NMR metabolomics
Measured: From ingestion of capsules to their excretion
Number of adverse events
Measured: From ingestion of capsules to their excretion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start10 Jun 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanessa Stadlbauer-Koellner, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Nimble Science Ltd.
- Responsible party
- Sponsor-investigator, Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
- Investigators
- Vanessa Stadlbauer-Köllner, Assoc. Prof., Principal investigator, Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708832
- Sponsor's protocol ID
- 1266/2024
- Acronym
- CAP
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules
- ClinicalTrials.gov ID
- NCT06708832
- Acronym / sponsor ID
- CAP / 1266/2024
- Conditions
- Liver Cirrhosis
- Keywords
- Microbiome, Metabolome, 16s rRNA, NMR, Pilot study, Duodenal microbiome, Liver Cirrhosis, SIMBA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Vanessa Stadlbauer-Koellner, MDUniversity, hospital or other
- Collaborators
- Nimble Science Ltd.
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 27 Nov 2024 (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.
In this study, the feasibility to use SIMBA (Small Intestinal MicroBiome Aspiration) capsules to collect small intestinal microbiome and metabolome information will be evaluated in patients with liver cirrhosis. Furthermore, the comparability oral, fecal and small intestinal microbiome and metabolome composition based on similarities and differences in 16s sequencing data and NMR metabolomics data will be evaluated.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIMBA ingestion | Experimental | Device: SIMBA ingestionParticipants will be prescreened for eligibility prior to obtaining informed consent. After informed consent is signed the participant will be screened and requested to complete a set of questionnaires prior to the ingestion of the SIMBA capsules. Then, a saliva and fecal sample will be collected and SIMBA capsules are ingested. The participant will be instructed on capsule ingestion. Retrieval of capsules occurs in their home environment. The participant is expected to continue searching their stool until both capsules are found. A fecal sample will be collected upon retrieval of first SIMBA capsule. After both capsules are collected the participants schedules an appointment to deliver the capsules to the study center and complete the second set of questionnaires. Additionally, saliva sample will be collected again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| SIMBA ingestionAlso: Small Intestine Microbiome Aspiration CapsulesIngestion of 2 SIMBA capsules at the same time and their excretion. | Device | SIMBA ingestion |
Primary outcome
Number of capsules successfully recovered
Time frame: From ingestion of capsules to their excretion
Number of capsules successfully recovered with sufficient amount of fluid collected for the analysis (absolute number, percentage)
7 secondary outcomes
Composition of the microbiome in capsule fluid (16s rRNA)
Time frame: From ingestion of capsules to their excretion
Composition of the microbiome in stool (16s rRNA)
Time frame: From ingestion of capsules to their excretion
Composition of the microbiome in saliva (16s rRNA)
Time frame: From ingestion of capsules to their excretion
Composition of the metabolome in capsule fluid (NMR)
Time frame: From ingestion of capsules to their excretion
Composition of the metabolome in saliva (NMR)
Time frame: From ingestion of capsules to their excretion
Composition of the metabolome in stool (NMR)
Time frame: From ingestion of capsules to their excretion
Number of adverse events
Time frame: From ingestion of capsules to their excretion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Vanessa Stadlbauer-Köllner, Assoc. Prof. principal investigator
Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMBA ingestion in people with Liver Cirrhosis, run by Vanessa Stadlbauer-Koellner, MD at 1 site in Austria.
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 16 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: finished, as of the sponsor's last update on 22 Jun 2026. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of capsules successfully recovered (time frame: From ingestion of capsules to their excretion). 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 22 Jun 2026.