To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules

NCT06708832 | Not Yet Recruiting DMC

• 1 other identifier: 1266/2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Composition of the microbiome in capsule fluid (16s rRNA)

  From ingestion of capsules to their excretion

• Composition of the microbiome in stool (16s rRNA)

  From ingestion of capsules to their excretion

• Composition of the microbiome in saliva (16s rRNA)

  From ingestion of capsules to their excretion

• Composition of the metabolome in capsule fluid (NMR)

  From ingestion of capsules to their excretion

• Composition of the metabolome in saliva (NMR)

  From ingestion of capsules to their excretion

Study Arms (1)

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.

Device: SIMBA ingestion

Interventions

SIMBA ingestion DEVICE

Ingestion of 2 SIMBA capsules at the same time and their excretion.

Also known as: Small Intestine Microbiome Aspiration Capsules

SIMBA ingestion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead
• Nimble Science Ltd.: collaborator

Study Sites (1)

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

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Stadlbauer-Köllner, Assoc. Prof.

  Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Stadlbauer-Köllner, Univ. Prof.

CONTACT

+43 316 385 82282; vanessa.stadlbauer@medunigraz.at

Angela Horvath, PD Dr.

CONTACT

+43 316 385 28805; angela.horvath@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 27, 2024
• Study Start: April 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

AU (1)