Healthy VolunteersDIGESTNCT05477069
Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine.
A study testing Innovative medical device for sampling small intestine content in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial summary
For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Innovative medical device for sampling small intestine content
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2022to 6 Nov 2023
- 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
- Able to understand the study and the associated instructions
- Aged ≥18 years and ≤65 years
- Fasting with water and food for at least 10 hours
- BMI between ≥20 and ≤30 kg/m².
- Transit evaluated at 1 to 3 bowel movements/day
- Maintain regular physical activity and eating habits for the duration of the study
Show all 10Show fewer
- Affiliated with a social security plan
- Have a freezer in their home and at work, if applicable
- Volunteer staying in the Isère department during the collection of the faeces (from 96 hours to 15 days max)
- Having signed the informed and collection consent
Who cannot join
- Subject :
- with medical treatment (except oral contraception and/or probiotics and related products)
- with lactose and fructose intolerance
- with of gastroparesis
- who had a colonoscopy preparation up to 1 month prior to inclusion
- in the exclusion period of another clinical investigation,
Show all 27Show fewer
- who receive more than 4500 euros of compensation due to his participation in other biomedical research in the 12 months preceding this study
- who cannot be contacted in case of emergency
- who has taken during the 15 days prior to inclusion and/or is scheduled to take the following treatments during the study: antidepressants, anxiolytics, antiparkinsonian agents, neuroleptics, antibiotics and prebiotics
- who has taken during the previous 7 days: at least once a treatment for irritable bowel syndrome (antispasmodics,..) or for constipation (laxative) or for diarrhea
- with a known food allergy
- who have to undergo colon surgery
- with intestinal obstruction history
- with hepatic, cardiac, congenital or renal comorbidity
- with long-standing diabetes
- with an inflammatory disease of the digestive tract, a history of digestive surgery
- who have been treated with radiotherapy or who have taken anti-inflammatory drugs for a long time
- with gastric fullness
- with known or suspected obstruction of the gastrointestinal tract (including known inflammatory bowel or intestinal diverticula)
- with presence of swallowing disorders or Zencker's diverticulum
- with nausea, deviated nasal septum
- with contraindications to esophageal tube placement (chronic esophageal pathology)
- drug or alcohol abuse (3 units for men and 2 units for women according to WHO criteria)
- with a known allergy to silicone or to iodine
- refusing medical imaging or surgery (in case of non-recovery of the capsule)
- protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code
- absence of highly effective contraception for women with childbearing capacity until the end of the cycle following the end of participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine. Functional Evaluation on the Transit of Healthy Volunteers. A First in Man, Prospective, Monocentric, Not Randomized Study.
For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked.
Read the detailed description
This medical device consists of a standard pill made of 3 capsules for the collection of intestinal microbiota. The pill is ingested by the volunteer and multi-omics analysis will be performed on intestinal fluid samples from the capsules and also on faeces.
First in man, involving a medical device, prospective, monocentric, not randomized, not controlled and open-label study.
- Conditions
- Healthy Volunteers
- Being tested
- Innovative medical device for sampling small intestine content
- Keywords
- Innovative medical device, Microbiota, Biochemically controlled capsule, Intestinal fluid sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative medical device for sampling small intestine contentDevice
Ingestion of the medical device by the volunteer
| Study group | Role | What they receive |
|---|---|---|
| First intervention group | Experimental | The volunteer ingests the medical device which passes through the body for a period of 12 to 24 hours. Capsules are collected and analysis on intestinal fluid and faeces are performed Receives: Device: Innovative medical device for sampling small intestine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the absence of adverse events (safety of the medical device) and that the device is analyzable (performance of the medical device).
Safety is assessed with the absence of grade >3 adverse events. Performance is assessed by the presence of at least one capsule found in the stool with a satisfactory visual condition of capsule and with a sufficient volume of its contents within 96 hours after ingestion.
The primary objective of this study is met if safety and performance are achieved for at least 12 of 15 volunteers.
Measured: From 96 hours to 15 days
Secondary outcomes (8)
Number and grade of adverse events collected during the capsule collection period
In order to verify the safe use of the medical device the number and grade of adverve events are collected from 96 hours to 1 month.
Measured: From 96 hours to 15 days
Number of capsules found to verify that the medical device passes through the human body
Recovery of 3 capsules per volunteer
Measured: From 96 hours to 15 days
Verify that the medical device has captured intestinal fluid
Measurement of the volume contained in each capsule.
Measured: From 96 hours to 15 days
Verify that the medical device has opened in the intestine
pH measurement of the contents of each capsule.
Measured: From 96 hours to 15 days
Absence of tears and detachment of the various elements of the capsule
Visual inspection of the capsule after collection to determine absence of tears and detachment of the various elements
Measured: From 96 hours to 15 days
Metagenomic analysis using 16s sequencing will provide data to establish differences in the gut microbiota profile/composition between capsule and faecal contents.
Metabolomic profile of capsule and faecal contents will be assessed by untargeted metabolomics. Identification, relative quantification and listing of metabolites specific to a sampling method will be generated.Microbiota will be described in terms of alpha and beta diversity, phylum, genus, OTU
Measured: From 96 hours to 15 days
Medical device usability and acceptability : descriptive analysis
Registration of volunteer sensation during medical device ingestion using a questionnaire without scale. A descriptive analysis will be done with the answers.
Measured: From 96 hours to 15 days
Obtain an overview of the sample's functional potential and identify biomarkers (organisms) via culturomics, on samples from up to 2 subjects.
Results of culturomic analysis of capsule contents, on up to 2 subjects.
Measured: From 96 hours to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start24 Oct 2022
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Pelican Health
- Responsible party
- Sponsor
- Investigators
- Nicolas Matthieu, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477069
- Sponsor's protocol ID
- 38RC18.011
- Acronym
- DIGEST
- Status last verified
- Dec 2023
- First submitted
- 17 Jun 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tronel A, Silvent AS, Buelow E, Giai J, Leroy C, Proust M, Martin D, Le Gouellec A, Soranzo T, Mathieu N. Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers. Methods Protoc. 2024 Feb 4;7(1):15. doi: 10.3390/mps7010015.
PubMed 38392689Tronel A, Roger-Margueritat M, Plazy C, Cunin V, Mohanty I, Dorrestein PC, Soranzo T, Le Gouellec A. Untargeted and semi-targeted metabolomics approach for profiling small intestinal and fecal metabolome using high-resolution mass spectrometry. Metabolomics. 2025 Jun 19;21(4):84. doi: 10.1007/s11306-025-02288-2.
PubMed 40537703
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine. Functional Evaluation on the Transit of Healthy Volunteers. A First in Man, Prospective, Monocentric, Not Randomized Study.
- ClinicalTrials.gov ID
- NCT05477069
- Acronym / sponsor ID
- DIGEST / 38RC18.011
- Conditions
- Healthy Volunteers
- Keywords
- Innovative medical device, Microbiota, Biochemically controlled capsule, Intestinal fluid sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Pelican Health
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 28 Jul 2022 (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.
For the first time in the world, the objective of this study is to evaluate on healthy volunteers, an innovative medical device for the capture of intestinal liquid.This medical device is not yet CE marked.
Detailed description
This medical device consists of a standard pill made of 3 capsules for the collection of intestinal microbiota. The pill is ingested by the volunteer and multi-omics analysis will be performed on intestinal fluid samples from the capsules and also on faeces.
First in man, involving a medical device, prospective, monocentric, not randomized, not controlled and open-label study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First intervention group | Experimental | Device: Innovative medical device for sampling small intestine contentThe volunteer ingests the medical device which passes through the body for a period of 12 to 24 hours. Capsules are collected and analysis on intestinal fluid and faeces are performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to understand the study and the associated instructions
- Aged ≥18 years and ≤65 years
- Fasting with water and food for at least 10 hours
- BMI between ≥20 and ≤30 kg/m².
- Transit evaluated at 1 to 3 bowel movements/day
Key exclusion criteria (27 listed)
- with medical treatment (except oral contraception and/or probiotics and related products)
- with lactose and fructose intolerance
- with of gastroparesis
- who had a colonoscopy preparation up to 1 month prior to inclusion
- in the exclusion period of another clinical investigation,
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 |
|---|---|---|
| Innovative medical device for sampling small intestine contentIngestion of the medical device by the volunteer | Device | First intervention group |
Primary outcome
Demonstrate the absence of adverse events (safety of the medical device) and that the device is analyzable (performance of the medical device).
Time frame: From 96 hours to 15 days
Safety is assessed with the absence of grade >3 adverse events. Performance is assessed by the presence of at least one capsule found in the stool with a satisfactory visual condition of capsule and with a sufficient volume of its contents within 96 hours after ingestion. The primary objective of this study is met if safety and performance are achieved for at least 12 of 15 volunteers.
8 secondary outcomes
Number and grade of adverse events collected during the capsule collection period
Time frame: From 96 hours to 15 days
Number of capsules found to verify that the medical device passes through the human body
Time frame: From 96 hours to 15 days
Verify that the medical device has captured intestinal fluid
Time frame: From 96 hours to 15 days
Verify that the medical device has opened in the intestine
Time frame: From 96 hours to 15 days
Absence of tears and detachment of the various elements of the capsule
Time frame: From 96 hours to 15 days
Metagenomic analysis using 16s sequencing will provide data to establish differences in the gut microbiota profile/composition between capsule and faecal contents.
Time frame: From 96 hours to 15 days
Medical device usability and acceptability : descriptive analysis
Time frame: From 96 hours to 15 days
Obtain an overview of the sample's functional potential and identify biomarkers (organisms) via culturomics, on samples from up to 2 subjects.
Time frame: From 96 hours to 2 months
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 13 Aug 2025.
- Results publication: PubMed 38392689Tronel A, Silvent AS, Buelow E, Giai J, Leroy C, Proust M, Martin D, Le Gouellec A, Soranzo T, Mathieu N. Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers. Methods Protoc. 2024 Feb 4;7(1):15. doi: 10.3390/mps7010015.
- Derived from this study: PubMed 40537703Tronel A, Roger-Margueritat M, Plazy C, Cunin V, Mohanty I, Dorrestein PC, Soranzo T, Le Gouellec A. Untargeted and semi-targeted metabolomics approach for profiling small intestinal and fecal metabolome using high-resolution mass spectrometry. Metabolomics. 2025 Jun 19;21(4):84. doi: 10.1007/s11306-025-02288-2.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Nicolas Matthieu, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative medical device for sampling small intestine content in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
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 10 inclusion and 27 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 13 Aug 2025. 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 France. 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?
Demonstrate the absence of adverse events (safety of the medical device) and that the device is analyzable (performance of the medical device). (time frame: From 96 hours to 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477069, which also lists 2 linked publications.
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 13 Aug 2025.