IBD (Inflammatory Bowel Disease)NCT06967311
Human and Microbial Determinants of the Onset of IBD Flares
An observational study of IBD (Inflammatory Bowel Disease), run by Viome at 1 site in Brazil.
Trial summary
This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2025to Feb 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with Crohn's Disease or Ulcerative Colitis that are patients at Universidade Federal de Santa Catarina (UFSC) Hospital and under care of Dr. Vivian Menegassi
Who may be able to join
- Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi
Who cannot join
- Cancer Diagnosis/Treatment
- Under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Momo Vuyisich Chief Science Officer, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
LABOX, Department of Biochemistry, Universidade Federal de Santa Catarina
Florianópolis, Santa Catarina, 88037-100
Alexandra Latini, PhD, 425-368-5248, studies@viome.com
About this study
Official title: Microbial and Human Determinants of the Onset of IBD Flares
This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.
Read the detailed description
This is a longitudinal observational study whose goals are to identify:
Microbial and human molecular triggers of IBD relapses, Microbial and human molecular pathways strongly associated with flares that could be targeted with nutrition with a therapeutic potential, Biomarkers of IBD for Dx purposes, Identify microbial functions associated with release of BH4.
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- observational, IBD, microbiome
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease (IBD) | Individuals diagnosed with IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbial KEGG orthologs (KOs) associated with IBD
Metatranscriptomic tests will be used to quantify microbial KOs in stool samples. At the end of the study, we will use machine learning to identify KOs whose expression is associated with IBD.
Measured: For 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start31 Jan 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by ViomeThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Santa Catarina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967311
- Sponsor's protocol ID
- V233
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial and Human Determinants of the Onset of IBD Flares
- ClinicalTrials.gov ID
- NCT06967311
- Acronym / sponsor ID
- V233
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- observational, IBD, microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Santa Catarina
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 13 May 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 will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.
Detailed description
This is a longitudinal observational study whose goals are to identify:
Microbial and human molecular triggers of IBD relapses, Microbial and human molecular pathways strongly associated with flares that could be targeted with nutrition with a therapeutic potential, Biomarkers of IBD for Dx purposes, Identify microbial functions associated with release of BH4.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease (IBD) | – | –Individuals diagnosed with IBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Crohn's Disease or Ulcerative Colitis that are patients at Universidade Federal de Santa Catarina (UFSC) Hospital and under care of Dr. Vivian Menegassi
Key inclusion criteria (1 listed)
- Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi
Key exclusion criteria (2 listed)
- Cancer Diagnosis/Treatment
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stool microbial KEGG orthologs (KOs) associated with IBD
Time frame: For 12 months from enrollment
Metatranscriptomic tests will be used to quantify microbial KOs in stool samples. At the end of the study, we will use machine learning to identify KOs whose expression is associated with IBD.
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 15 Jun 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.
Momo Vuyisich Chief Science Officer, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease), run by Viome at 1 site in Brazil.
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 1 inclusion and 2 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 15 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 Brazil. 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?
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 Raquel Clinical Research Coordinator (425-368-5248, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool microbial KEGG orthologs (KOs) associated with IBD (time frame: For 12 months from enrollment). 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 15 Jun 2025.