Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06756100

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

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

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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, to understand how the gut microbiome's composition and function can predict disease progression during the first year after diagnosis. The study aims to identify biomarkers related to gut microbial metabolites that may help guide early treatment decisions and avoid unnecessary exposure to expensive therapies. This research focuses on newly diagnosed patients to capture early disease changes before treatment escalation is needed. The study involves collecting fecal samples and mucosal-luminal interface aspirates at the time of colonoscopy from treatment-naïve IBD patients and controls with similar gastrointestinal symptoms but without IBD. Researchers will analyze the microbial and metabolomic profiles, including short chain fatty acids and secondary bile acids, to find patterns linked to disease progression. The capacity of gut microbes to produce these metabolites will also be tested in laboratory bioreactors simulating the gut environment. Participants will be monitored for up to 36 months, with the main focus on the first 12 months after diagnosis. Researchers will track clinical outcomes and need for treatment escalation, correlating these with microbiome data. Various assessments include colonoscopy, biopsy, microbial and metabolomic profiling, and host gene expression analysis. The goal is to find reliable biomarkers that predict early disease course and support personalized medicine in IBD care.

CONDITIONS

Brief 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 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo diagnostic colonoscopy and biopsy to confirm or rule out inflammatory bowel disease (IBD). Samples of fecal, mucosal-luminal interface aspirates, and biopsies are collected for microbiome and metabolomic profiling.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 36 months

Participants with confirmed IBD are monitored to assess gut microbiome composition and function and the need for therapy escalation over time. This includes collection of clinical outcomes and biological samples.

Periodic visits over 36 months

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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