CompletedNCT06708832CAPUpdated Jun 22, 2026

To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules

An interventional study of SIMBA ingestion in Liver Cirrhosis, sponsored by Vanessa Stadlbauer-Koellner, MD. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Vanessa Stadlbauer-Koellner, MD · Not applicable, Interventional, and Device feasibility

Phase: Not applicable
Study type: Interventional
Enrollment: 11
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Liver Cirrhosis

Browse trials for

Liver Cirrhosis 1,642

Keywords

Microbiome
Metabolome
16s rRNA
NMR
Pilot study
Duodenal microbiome
Liver Cirrhosis
SIMBA
Capsule
Metabolomics

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Vanessa Stadlbauer-Koellner, MD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 11 participants (actual)

Study arms

Experimental
SIMBA ingestion
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.
Device: SIMBA ingestion

Interventions

DeviceSIMBA ingestion
Ingestion of 2 SIMBA capsules at the same time and their excretion.
Also known as: Small Intestine Microbiome Aspiration Capsules

What researchers measure

Primary outcomes

Number of capsules successfully recovered
Number of capsules successfully recovered with sufficient amount of fluid collected for the analysis (absolute number, percentage)
Time frame: From ingestion of capsules to their excretion

Secondary outcomes

Composition of the microbiome in capsule fluid (16s rRNA)
Composition of the microbiome in capsule fluid measured by 16s rRNA sequencing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From ingestion of capsules to their excretion
Composition of the metabolome in saliva (NMR)
Composition of the metabolome in saliva measured by NMR metabolomics
Time frame: From ingestion of capsules to their excretion
Composition of the metabolome in stool (NMR)
Composition of the metabolome in stool measured by NMR metabolomics
Time frame: From ingestion of capsules to their excretion
Number of adverse events
Time frame: From ingestion of capsules to their excretion

Study locations

1 site

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic
Graz, 8010, Austria

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06708832
Lead sponsor: Vanessa Stadlbauer-Koellner, MD
Collaborators: Nimble Science Ltd.
Responsible party: Vanessa Stadlbauer-Koellner, MD (Univ.-Prof.in Priv.-Doz.in Dr.in med.univ. Vanessa Stadlbauer-Köllner, MBA, Medical University of Graz) — Sponsor-investigator
First posted: Nov 27, 2024
Start date: Jun 10, 2025
Primary completion: Jul 16, 2025
Completion: Jul 16, 2025
Last update: Jun 22, 2026

Study contacts

Vanessa Stadlbauer-Köllner, Assoc. Prof.

principal investigator · Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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