Healthy SubjectsPhase 1NCT07054593
Effect of Proton Pump Inhibitors on Gut Microbiota Composition and Metabolites in Healthy Subjects Using CapScan
A Phase 1 study testing CapScan in people with Healthy Subjects, run by Envivo Bio Inc at 1 site in United States.
Trial summary
This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CapScan
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study:
- Males or females 18 years of age or older and 85 years of age or younger at the time of the first Screening Visit.
- ASA Classification 1 or 2.
- For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
- Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
Who cannot join
- Subjects with any of the following conditions or characteristics must be excluded from the study:
- History of any of the following:
- prior gastric or esophageal surgery, including bariatric surgery
- bowel obstruction
- gastric outlet obstruction
- gastroparesis
Show all 16Show fewer
- acute diverticulitis
- inflammatory bowel disease
- ileostomy or colostomy
- gastric or esophageal cancer
- achalasia
- active dysphagia or odynophagia
- Daily PPI use in the last 30 days
- Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
- A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Silicon Valley Gastroenterology
Mountain View, California, 94040
About this study
Official title: An Open-Label, Pilot Study Designed To Evaluate The Effect Of A Proton Pump Inhibitor On The Regional Composition Of The Gut Microbiota And Metabolic Profiles Of Health Volunteers Using The Capscan® Samplng Capsule
This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.
Read the detailed description
Prospective, open-label, single-arm, non-randomized, single-center study designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.
- Conditions
- Healthy Subjects
- Being tested
- CapScan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapScanDevice
Gut sampling capsule
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
A primary endpoint is to identify and quantitate the relative abundance of the gut microbial taxa using at least 3 million metagenomic DNA sequencing reads in at least 75% of the samples obtained from the CapScan devices.
Measured: 2 months
Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices
A primary endpoint is to identify at least 1,500 annotated gut metabolites from the intestinal tract in at least 75% of the samples obtained from the CapScan devices.
Measured: 2 months
Secondary outcomes (2)
Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment
Evaluate the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of the study population from before and after omeprazole treatment.
Measured: 2 months
Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment
Evaluate the diversity, centroids and distributions of gut metabolites in CapScan samples of the study population from before and after omeprazole treatment.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Envivo Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054593
- Sponsor's protocol ID
- EB02
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study Designed To Evaluate The Effect Of A Proton Pump Inhibitor On The Regional Composition Of The Gut Microbiota And Metabolic Profiles Of Health Volunteers Using The Capscan® Samplng Capsule
- ClinicalTrials.gov ID
- NCT07054593
- Acronym / sponsor ID
- EB02
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Envivo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.
Detailed description
Prospective, open-label, single-arm, non-randomized, single-center study designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 18 years of age or older and 85 years of age or younger at the time of the first Screening Visit.
- ASA Classification 1 or 2.
- For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
- Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
Key exclusion criteria (16 listed)
- Subjects with any of the following conditions or characteristics must be excluded from the study:
- History of any of the following:
- Daily PPI use in the last 30 days
- Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
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 |
|---|---|---|
| CapScanGut sampling capsule | Device | – |
Primary outcome
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices
Time frame: 2 months
A primary endpoint is to identify and quantitate the relative abundance of the gut microbial taxa using at least 3 million metagenomic DNA sequencing reads in at least 75% of the samples obtained from the CapScan devices.
Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices
Time frame: 2 months
A primary endpoint is to identify at least 1,500 annotated gut metabolites from the intestinal tract in at least 75% of the samples obtained from the CapScan devices.
2 secondary outcomes
Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment
Time frame: 2 months
Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CapScan in people with Healthy Subjects, run by Envivo Bio Inc at 1 site in United States.
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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 8 Jul 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Taufui (650-988-7530, svgistaff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices (time frame: 2 months). The study lists 2 primary outcomes in all. 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 Jul 2025.