Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06756100

Composition and Metabolic Activity of Gut Microbiota to Predict Early Progression of Inflammatory Bowel Disease

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-01-01

140

Participants Needed

1

Research Sites

194 weeks

Total Duration

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Sponsors

P

Pontificia Universidad Catolica de Chile

Lead Sponsor

F

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, which causes inflammation in the digestive tract with periods of active symptoms and remission. The study aims to evaluate how the gut microbiome's composition and function can predict the course of IBD during the first year after diagnosis, focusing on whether gut microbial metabolites can indicate the need for early treatment escalation. Participants newly diagnosed with IBD will be enrolled before their first colonoscopy. Researchers will collect and analyze fecal samples and mucosal-luminal interface aspirates to study gut microbiome and metabolite profiles, including short-chain fatty acids and secondary bile acids. They will also examine how these microbial factors affect gene expression in the gut lining and test the gut bacteria's capacity to produce these metabolites in laboratory conditions. During the study, participants will provide biological samples and undergo colonoscopy. Researchers will compare microbiome data with clinical outcomes, particularly the need for treatment escalation within the first year. The study will last up to 36 months to observe microbiome changes and disease progression. The goal is to identify biomarkers that help guide early, personalized treatment approaches for IBD patients.

CONDITIONS

Official Title

Early Inflammatory Bowel Disease Progression

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with with at least 3 weeks of gastrointestinal symptoms including diarrhea, rectal bleeding, abdominal pain, tenesmus or urgency
Not Eligible

You will not qualify if you...

  • Confirmed infectious disease of the gastrointestinal tract

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pontificia Universidad Catolica of Chile

Santiago, Chile

Actively Recruiting

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Research Team

C

Cristian Hernández-Rocha, MD

M

Manuel Álvarez-Lobos, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Composition and Metabolic Activity of Gut Microbiota to Predict Early Progression of Inflammatory Bowel Disease | DecenTrialz