Proof of ConceptNCT04489329
Dietary Intervention Detection in the Small Intestine
A study testing Ingestible Capsule and Probiotic in people with Proof of Concept, run by Nimble Science Ltd. at 1 site in Canada.
Trial summary
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Proof of Concept
- What is being tested?
- Ingestible Capsule and Probiotic
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Dec 2020to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- Healthy
- On no medication, or on stable doses of medications which will not be changed over the course of the study
- Willingness to maintain their usual dietary habits and physical activity
- Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.
- Ability to understand and provide informed consent
- Ability and willingness to meet the required schedule and study tasks and interventions
- Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)
Who cannot join
- History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
- Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
- Use of other investigational product within 3 months of start of the study.
- Suffering from immune disorders or with possible immune deficient status
- Allergy to soy or milk.
- Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small or large intestine (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment).
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- Use of any medications in the previous 7 days that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).
- Body Mass Index (BMI) > 38.
- Previous history of gastric bezoar or gastroparesis.
- Any abdominal or pelvic surgery within the past 3 months.
- Known history of inflammatory bowel disease and/or Crohn's disease.
- History of diverticulitis, diverticular stricture, or other intestinal strictures.
- History of abdominal or pelvic radiotherapy.
- History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
- Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
- Colon cleansing prep for 1 month before the first visit, or during the study.
- Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
- < 2 bowel movements per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
- Conditions
- Proof of Concept
- Being tested
- Ingestible Capsule, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestible CapsuleDevice
Participants will swallow capsule and undergo X-rays to establish transit
ProbioticDietary supplement
Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Participant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline. Receives: Device: Ingestible Capsule; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial density count
density count of probiotic strain compared between capsule and stool sample (CFU/ml)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start22 Dec 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proof of ConceptStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary, Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Chris Andrews, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489329
- Sponsor's protocol ID
- REB 20-1211
- Status last verified
- Sep 2021
- First submitted
- 23 Jul 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine
- ClinicalTrials.gov ID
- NCT04489329
- Acronym / sponsor ID
- REB 20-1211
- Conditions
- Proof of Concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nimble Science Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary, Lallemand Health Solutions
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Ingestible Capsule, Dietary Supplement: ProbioticParticipant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 65 years old
- Healthy
- On no medication, or on stable doses of medications which will not be changed over the course of the study
- Willingness to maintain their usual dietary habits and physical activity
- Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.
Key exclusion criteria (18 listed)
- History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
- Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
- Use of other investigational product within 3 months of start of the study.
- Suffering from immune disorders or with possible immune deficient status
- Allergy to soy or milk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestible CapsuleParticipants will swallow capsule and undergo X-rays to establish transit | Device | Single Arm |
| ProbioticParticipants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine. | Dietary supplement | Single Arm |
Primary outcome
Bacterial density count
Time frame: 7 days
density count of probiotic strain compared between capsule and stool sample (CFU/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Andrews, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestible Capsule and Probiotic in people with Proof of Concept, run by Nimble Science Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial density count (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.