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Recruiting

NCT Number: NCT06967311

Human and Microbial Determinants of the Onset of IBD Flares

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

Recruiting

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LABOX, Department of Biochemistry, Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88037-100, Brazil

Location status: Recruiting

Location contact

Alexandra Latini, PhD

CONTACT

[email protected]

425-368-5248

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Momo Vuyisich Chief Science Officer, PhD

CONTACT

[email protected]

Raquel Clinical Research Coordinator

CONTACT

[email protected]

425-368-5248

Sponsors and collaborators

Lead sponsor

Viome

Industry

Collaborators

  • Universidade Federal de Santa Catarina

Registry information

Official study title

Microbial and Human Determinants of the Onset of IBD Flares

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 13, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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