Human and Microbial Determinants of the Onset of IBD Flares

Microbial and Human Determinants of the Onset of IBD Flares

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06967311

Enrollment

100

Registered

2025-05-13

Start date

2025-01-31

Completion date

2030-02-28

Last updated

2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

observational, IBD, microbiome

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Cancer Diagnosis/Treatment * Under 18 years old

Design outcomes

Primary

Measure	Time frame	Description
Stool microbial KEGG orthologs (KOs) associated with IBD	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.

Countries

Brazil

Contacts

Primary ContactRaquel Clinical Research Coordinator

studies@viome.com425-368-5248

Backup ContactMomo Vuyisich Chief Science Officer, PhD

studies@viome.com

Outcome results