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Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

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ClinicalTrials.gov Identifier: NCT05633706
Recruitment Status : Recruiting
First Posted : December 1, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Nimble Science Ltd.

Brief Summary:
The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Crohn Disease Celiac Disease Ulcerative Colitis Functional Dyspepsia Device: fluid biopsy capsule

Detailed Description:
The investigators primary goal is to assess the correlation of gut symptoms from various disease states with the dysbiosis of the small intestinal microbiome and metabolites collected by the SIMBA capsule, and as identified and measured by metagenomic sequencing and/or metabolomics approaches. The process consists of ingestion and collection of up to 4 SIMBA capsules, on up to 2 separate occasions, along with collection of a stool sample at the same time. Participants will also fill out a series of questionnaires on medical history and lifestyle inputs (eg. diet, exercise, mental health) GI symptoms, anxiety, and depression. The investigators ultimate goal will be to develop a better understanding of how the small intestinal microbiome might play a role in symptom generation, to establish whether the SIMBA capsule can find a signature of dysbiosis which can be used as a biomarker for a number of functional gut disorders.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis
Estimated Study Start Date : January 9, 2023
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Healthy
Not belonging to the other cohorts as described below.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Irritable Bowel Syndrome
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Crohns Disease
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Ulcerative Colitis
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Celiac Disease
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Functional Dyspepsia
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
Device: fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule




Primary Outcome Measures :
  1. Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping. [ Time Frame: baseline, pre-procedure ]
    The bacterial composition of healthy control fluid biopsy is compared to the bacterial composition of participants with diagnosed gastrointestinal diseases, to aid in gastrointestinal disease biomarker discovery.


Secondary Outcome Measures :
  1. Correlation of bacterial composition with dietary intake as assessed by PLS-DA mapping. [ Time Frame: baseline, pre-procedure ]
    Fluid biopsy bacterial composition correlated with self-reported long-term and short-term preferred variations in intake of dietary fiber and organic food.


Other Outcome Measures:
  1. Usability of SIMBA capsule in various disease states as assessed by SIMBA-experience questionnaires. [ Time Frame: immediately after the procedure ]
    Participant feedback on SIMBA capsule usage experience will inform usability data.

  2. Comparison of SIMBA fluid biopsy microbial composition to stool microbial composition as assessed by 16s rRNA metagenomic analysis. [ Time Frame: baseline, pre-procedure ]
  3. Correlations of bacterial composition with anxiety (GAD-7) scores as assessed by PCoA mapping, alpha and beta diversity analysis. [ Time Frame: baseline, pre-procedure ]
  4. Correlations of bacterial composition with depression (PHQ-8) scores as assessed by PCoA mapping, alpha and beta diversity analysis. [ Time Frame: baseline, pre-procedure ]
  5. Correlations of bacterial composition with self-reported lifestyle behaviours as assessed by PCoA mapping, alpha and beta diversity analysis. [ Time Frame: baseline, pre-procedure ]
  6. Number of participants with device-related adverse events as assessed by an independent Data Safety Monitoring Board. [ Time Frame: through study completion, an average of 8 days ]
  7. Evaluate the usability of excreted SIMBA Capsule retrieval procedures as assessed by retrieval-experience questionnaire feedback. [ Time Frame: immediately after the procedure ]

Biospecimen Retention:   Samples With DNA
Fluid from the small intestine, stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Up to 150 individuals, females or males will be enrolled in this study.
Criteria

Inclusion Criteria:

  1. Aged between 18 and 80 years.
  2. No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia by participant self-report (Control group).
  3. Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, or Functional Dyspepsia by a relevant physician, nutritionist, naturopath, etc, and willingness to provide documentation to confirm this diagnosis or have a consultation with the PI. (Disease group).
  4. Ability to understand and provide informed consent.
  5. Ability and willingness to meet the required schedule, study interventions, and questionnaire requirements.
  6. No planned change in diet or medical interventions during the study duration.

Exclusion Criteria:

  1. Known disease which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable). The main deciding factor would be a history of obstructive symptoms in the previous 3 months prior to entry.
  2. Use of any medications or having undergone procedures in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA) (Control Group only).
  3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
  4. Females of childbearing age who are pregnant or lactating by self-report. (should an X-ray be required for confirmation of capsule passage, a urine pregnancy test will be administered beforehand).
  5. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
  6. < 2 bowel movements per week (Control Group only).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633706


Contacts
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Contact: Sabina Bruehlmann, PhD 4038625777 sabina@nimblesci.com
Contact: Joseph Wang, PhD joseph@nimblesci.com

Locations
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Canada, Alberta
Nimble Science Recruiting
Calgary, Alberta, Canada, T2P 3P2
Contact: Sabina Bruehlmann, PhD    4038625777    sabina@nimblesci.com   
Contact: Joseph Wang, PhD       joseph@nimblesci.com   
Principal Investigator: Chris Andrews, MD         
Sponsors and Collaborators
Nimble Science Ltd.
Investigators
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Principal Investigator: Chris Andrews, MD Nimble Science Ltd.
Principal Investigator: Matthew Woo, MD Nimble Science Ltd.
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Responsible Party: Nimble Science Ltd.
ClinicalTrials.gov Identifier: NCT05633706    
Other Study ID Numbers: HREBA.CTC-22-0096
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Irritable Bowel Syndrome
Celiac Disease
Dyspepsia
Dysbiosis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Colonic Diseases, Functional
Signs and Symptoms, Digestive
Malabsorption Syndromes
Metabolic Diseases
Pathologic Processes