Small Intestinal Bacterial OvergrowthPhase 1NCT06298409
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
A Phase 1 study testing CapScan collection capsule in people with Small Intestinal Bacterial Overgrowth, run by Envivo Bio Inc at 1 site in United States.
Trial summary
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth
- What is being tested?
- CapScan collection capsule
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 28 Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 years of age or older and 80 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.
- Positive for at least one clinical symptom consistent with SIBO.
- Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
- Prescribed, but has not started, a two-week course of Rifaximin for SIBO.
Who cannot join
- History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
- Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
- 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, 1 recruiting
- Recruiting
Silicon Valley Gastroenterology
Mountain View, California, 94040
Jennifer Taufui, svgistaff@gmail.com
About this study
Official title: Evaluating the Effect of Rifaximin on the Regional Composition of the Gut Microbiota and Metabolic Profiles of Subjects With SIBO Using the CapScan® Collection Capsule
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
Read the detailed description
Prospective, open-label, single-arm, non-randomized, multi-center study designed to evaluate the effect of the antibiotic rifaximin on the regional composition of the gut microbiota and metabolic profiles of subjects diagnosed with SIBO, using the CapScan collection capsule.
- Conditions
- Small Intestinal Bacterial Overgrowth
- Being tested
- CapScan collection capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapScan collection capsuleDevice
The CapScan collection capsule is a single-use device that collects fluids from the gastrointestinal tract for analysis ex-vivo.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sampling of gut microbiota
> 75% of the retrieved CapScan devices to provide at least 3 million metagenomic DNA sequencing reads of gut microbes from the intestinal tract, and at least 900 annotated gut metabolites.
Measured: 56 days
Sampling of gut metabolome
>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.
Measured: 56 days
Secondary outcomes (2)
Effect of rifaximin on gut microbiota
Determine the effect of rifaximin on the regional compositions of the gut microbiota among SIBO patients by assessing the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of each subject before and after rifaximin at 5 time points.
Measured: 56 days
Effect of rifaximin on gut metabolome
Determine the effect of rifaximin on the regional compositions of the gut metabolites among SIBO patients by assessing the changes to metabolite classes and metabolic pathways as measured by LC/MS-MS analysis of CapScan samples for each subject before and after rifaximin at 5 time points.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Feb 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Envivo Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Triadafilopoulos, Principal investigator, Silicon Valley Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298409
- Sponsor's protocol ID
- EB04
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Rifaximin on the Regional Composition of the Gut Microbiota and Metabolic Profiles of Subjects With SIBO Using the CapScan® Collection Capsule
- ClinicalTrials.gov ID
- NCT06298409
- Acronym / sponsor ID
- EB04
- Conditions
- Small Intestinal Bacterial Overgrowth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Envivo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Mar 2024 (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.
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
Detailed description
Prospective, open-label, single-arm, non-randomized, multi-center study designed to evaluate the effect of the antibiotic rifaximin on the regional composition of the gut microbiota and metabolic profiles of subjects diagnosed with SIBO, using the CapScan collection capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females 18 years of age or older and 80 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 (5 listed)
- History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
- Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
- 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
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 |
|---|---|---|
| CapScan collection capsuleThe CapScan collection capsule is a single-use device that collects fluids from the gastrointestinal tract for analysis ex-vivo. | Device | – |
Primary outcome
Sampling of gut microbiota
Time frame: 56 days
> 75% of the retrieved CapScan devices to provide at least 3 million metagenomic DNA sequencing reads of gut microbes from the intestinal tract, and at least 900 annotated gut metabolites.
Sampling of gut metabolome
Time frame: 56 days
>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.
2 secondary outcomes
Effect of rifaximin on gut microbiota
Time frame: 56 days
Effect of rifaximin on gut metabolome
Time frame: 56 days
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
George Triadafilopoulos principal investigator
Silicon Valley Gastroenterology
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 collection capsule in people with Small Intestinal Bacterial Overgrowth, 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Jun 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?
Sampling of gut microbiota (time frame: 56 days). 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 11 Jun 2025.