Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
A long-term study that profiles immune cells, genes, diet, and the microbiome could help identify biomarkers that predict flares or response to therapy, which matters to people living with Crohn’s or ulcerative colitis.
Because it collects repeated imaging, biospecimens, and endoscopic assessments, it may generate insights into how disease activity changes over time and how treatments affect immune signatures.
Adults with Crohn’s disease or ulcerative colitis, relatives interested in genetic studies, clinicians and researchers focused on IBD immunology, biomarker discovery, and diet–microbiome interactions.
What To Know
This ClinicalTrials.gov record describes a planned NIH observational natural-history study (not yet recruiting) to follow adults with Crohn’s disease, ulcerative colitis, or other IBD and some healthy relatives over time with deep immunophenotyping and multi-omic sampling.
Participants will have regular clinic visits every 6 months for at least 3 years with blood and stool collection, ultrasound, MRI, endoscopy (colonoscopy for all; upper endoscopy for some), tissue biopsies, questionnaires, and nutritional/dietary assessments.
The study aims to identify immune and genetic biomarkers, molecular signatures tied to disease activity and treatment response, and links between diet/nutrition and the microbiome. This is an observational, hypothesis-generating registry-style study collecting specimens and clinical data rather than testing a specific experimental treatment.
Enrollment is planned for about 100 participants and the record is marked NOT_YET_RECRUITING at a single site (NIDDK/NIH).
This is a registered observational trial (ClinicalTrials.gov NCT07619547) that is NOT_YET_RECRUITING and is designed to collect longitudinal data and biospecimens; it does not test a new therapy. Findings will be hypothesis-generating and will require independent validation. The extraction is from the trial record (partial extraction).
