A Study to Collect Biospecimens (Blood, Stool and Intestinal Biopsies) to Support the Development of Specific Biomarkers of Treatment Response to Infliximab and Vedolizumab in Children with IBD
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009721
Sponsor Protocol Number: 17-009721
About this study
This study will be a multi-center, longitudinal, observational investigation to collect biospecimens (blood, stool and intestinal biopsies) to support the development of specific biomarkers of treatment response to infliximab and vedolizumab in children with IBD.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Ages 1-22 years
- Diagnosis of Crohn’s disease, ulcerative colitis or inflammatory bowel disease-unspecified who are referred to start infliximab or vedolizumab infusions
Exclusion Criteria
- Enteric infection within two weeks prior to start of infliximab or vedolizumab
- Subject is pregnant
- For those beginning infliximab treatment, prior exposure to anti-TNFαtherapies (infliximab, adalimumab, certolizumab pegol, golimumab or any anti-TNFαbiosimilar)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Stephens, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available