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| Name | Class |
|---|---|
| Nimble Science Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMBA ingestion | Device | Ingestion of 2 SIMBA capsules at the same time and their excretion. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Stadlbauer-Köllner, Assoc. Prof. | Medical University of Graz Department of Gastroenterology and Hepatology Auenbruggerplatz 15 8036 Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Division of Gastroenterology and Hepatology, Liver study clinic | Graz | 8010 | Austria |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |