To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules

Not Applicable

Not yet recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06708832
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Study Start: 2025-04-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic; 🇦🇹 Graz, Austria