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

Medical University of Graz

Status: Not yet enrolling

Conditions: Liver Cirrhosis

Treatments: Device: SIMBA ingestion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06708832

1266/2024

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SIMBA ingestion

Experimental group

Description:

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.

Treatment:

Device: SIMBA ingestion