Clinical trial NCT06708832: To Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules
Official title: Pilot Study to Evaluate the Feasibility of Collecting Duodenal Fluid With SIMBA Capsules
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Microbiome
Metabolome
16s rRNA
NMR
Pilot study
Duodenal microbiome
Liver Cirrhosis
SIMBA
Capsule
Metabolomics
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Nimble Science Ltd.
First posted: 2024-11-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of capsules successfully recovered
timeFrame: From ingestion of capsules to their excretion
Secondary outcomes:
measure: Composition of the microbiome in capsule fluid (16s rRNA)
timeFrame: From ingestion of capsules to their excretion
measure: Composition of the microbiome in stool (16s rRNA)
timeFrame: From ingestion of capsules to their excretion
measure: Composition of the microbiome in saliva (16s rRNA)
timeFrame: From ingestion of capsules to their excretion
measure: Composition of the metabolome in capsule fluid (NMR)
timeFrame: From ingestion of capsules to their excretion
measure: Composition of the metabolome in saliva (NMR)
timeFrame: From ingestion of capsules to their excretion
measure: Composition of the metabolome in stool (NMR)
timeFrame: From ingestion of capsules to their excretion
measure: Number of adverse events
timeFrame: From ingestion of capsules to their excretion
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic
Study officials:
affiliation: Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz
name: Vanessa Stadlbauer-Köllner, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: