To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules (CAP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Device: SIMBA ingestion

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Stadlbauer-Köllner, Univ. Prof.; Phone Number: +43 316 385 82282; Email: vanessa.stadlbauer@medunigraz.at
• Study Contact Backup: Name: Angela Horvath, PD Dr.; Phone Number: +43 316 385 28805; Email: angela.horvath@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8010
    • Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic
    • Contact: Lavra Celcer, MPharm; Phone Number: 00431638531547; Email: gestudien@medunigraz.at
    • Contact: Nicole Feldbacher, BSc; Phone Number: +43 316 385 78014; Email: gestudien@medunigraz.at
    • Principal Investigator: Vanessa Stadlbauer-Köllner, Assoc. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; Ingestion of 2 SIMBA capsules at the same time and their excretion.; Other Names: Small Intestine Microbiome Aspiration Capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Nimble Science Ltd.
• Investigators: Principal Investigator: Vanessa Stadlbauer-Köllner, Assoc. Prof., Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Liver Cirrhosis; Metabolomics; Capsule; Pilot study; NMR; Metabolome; 16s rRNA; Duodenal microbiome; SIMBA
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 1266/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No