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

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

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

Clinical Trials