NCT06756100|RecruitingDMC
Early Inflammatory Bowel Disease Progression
PRO-IBD
Composition and Metabolic Activity of Gut Microbiota to Predict Early Inflammatory Bowel Disease Progression
Loading search results
PRO-IBD
Composition and Metabolic Activity of Gut Microbiota to Predict Early Inflammatory Bowel Disease Progression
Sponsor study identifier
observational
140
1 country
1
Study Start
July 7, 2023
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2023
Actual (reported)September 30, 2024
Actual (reported)January 1, 2025
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patients with gastrointestinal symptoms for at least 3 weeks suggesting IBD in whom IBD is confirmed
Patients with gastrointestinal symptoms for at least 3 weeks suggesting IBD in whom IBD is ruled-out
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
Pontificia Universidad Catolica of Chile
Santiago, Chile
Blood (DNA and serum), stool and biopsy samples (obtained during colonoscopy). Mucosal-luminal interface samples (Mucosal lavage samples)
Cristian Hernández-Rocha, MD
Pontificia Universidad Catolica of chile
First Submitted
September 30, 2024
First Posted
January 1, 2025
Study Start
July 7, 2023
Actual (reported)Primary Completion
April 2027
EstimatedSexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 1, 2025
Record last verified: 2024-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: