NCT06967311

Brief Summary

This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
46mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2025Feb 2030

Study Start

First participant enrolled

January 31, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

March 28, 2025

Last Update Submit

June 12, 2025

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

observationalIBDmicrobiome

Outcome Measures

Primary Outcomes (1)

  • 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.

    For 12 months from enrollment

Study Arms (1)

Inflammatory Bowel Disease (IBD)

Individuals diagnosed with IBD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi

You may not qualify if:

  • Cancer Diagnosis/Treatment
  • Under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LABOX, Department of Biochemistry, Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88037-100, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect and retain whole blood, dried blood spots, stool, and saliva

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Raquel Clinical Research Coordinator

CONTACT

425-368-5248studies@viome.com

Momo Vuyisich Chief Science Officer, PhD

CONTACT

studies@viome.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

May 13, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations

BR(1)