Early Inflammatory Bowel Disease Progression

NCT06756100 | Recruiting DMC

• 1 other identifier: 1230757
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the capacity of the gut microbial composition and function to predict the course of IBD during the first year after diagnosis.

Conditions

Inflammatory Bowel Diseases; Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

Inflammatory bowel disease; Microbiome; Prediction

Outcome Measures

Primary Outcomes (2)

• Compare gut microbiome composition and function from different sample types among participants with gastrointestinal symptoms with and without confirmed IBD by colonoscopy and biopsy

  Researchers will obtain stool (before diagnostic colonoscopy), biopsy specimens (frozen and RNAlater stored samples), and intestinal washing (mucosal-luminal interface samples at colonoscopy)

  36 months

• In patients with confirmed IBD, researchers will identify whether there are differences in gut microbiome composition and function between patients who need therapy escalation (progressors) within the first 12 months after diagnosis

  IBD patients who need therapy escalation (progressors) will be those who: * Undergo surgery (colectomy or small bowel resection) within the first year after diagnosis * Start biologic therapy within the first year after diagnosis * Do not achieve clinical remission at week 24 (Average daily stool frequency (SF) ≤1.5 and abdominal pain (AP) score ≤1.0 for Crohn's disease (CD), and rectal bleeding (RB) = 0 and SF score \<2 on the patient reported outcome measure (PROM) component of the Mayo score for ulcerative colitis (UC) and IBD-unclassified (IBD-U). * IBD patients with fecal calprotectine ≥250 mcg/g at week 24

  12 months

Study Arms (2)

IBD

Patients with gastrointestinal symptoms for at least 3 weeks suggesting IBD in whom IBD is confirmed

Controls

Patients with gastrointestinal symptoms for at least 3 weeks suggesting IBD in whom IBD is ruled-out

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients attending the gastroenterology clinic at Pontificia Universidad Católica of Chile with at least 3 weeks of GI symptoms including diarrhea, rectal bleeding, abdominal pain, tenesmus or urgency will be identified by members of the Gastroenterology Medical Group. As part of standard of care (SOC), these patients will undergo stool testing to rule out gastrointestinal infections followed by full colonoscopy

You may qualify if:

• Adult patients with with at least 3 weeks of gastrointestinal symptoms including diarrhea, rectal bleeding, abdominal pain, tenesmus or urgency

You may not qualify if:

• Confirmed infectious disease of the gastrointestinal tract

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fondo Nacional de Desarrollo CientÃ-fico y Tecnológico, FONDECYT (Chile).: collaborator

Study Sites (1)

Pontificia Universidad Catolica of Chile

Santiago, Chile

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (DNA and serum), stool and biopsy samples (obtained during colonoscopy). Mucosal-luminal interface samples (Mucosal lavage samples)

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Cristian Hernández-Rocha, MD

  Pontificia Universidad Catolica of chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian Hernández-Rocha, MD

CONTACT

56-22-3543822; caherna4@uc.cl

Manuel Álvarez-Lobos, MD

CONTACT

56-22-3543822; manalvarezl@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: January 1, 2025
• Study Start: July 7, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CL (1)