Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Kristi C Briggs, M.D.
CONTACT
Lead
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Description: This is a single-site, hypothesis-generating natural history study aiming to follow participants with inflammatory bowel disease. Participants will be followed long-term with a focus on immunophenotyping their conditions. Adult family members of participants will also be invited to enroll to provide blood samples for immune and genetic analyses. Objectives: Primary Objective: To collect longitudinal clinical data and specimens, with the goal of identifying novel biomarkers correlating with disease activity or response to therapy Secondary Objectives: 1. To identify the dynamic molecular and immunological changes associated with chronic GI inflammation and mechanisms of response to FDA approved (biologic and small molecule inhibitors) therapies for IBD 2. To study the molecular genetics underlying chronic GI inflammation 3. To longitudinally quantify and characterize the nutritional status, food components, and overall diet of patients with IBD Endpoints: Primary Endpoint: 1\. Longitudinal collection of clinical data, biospecimens, and disease assessments at 6-month intervals over at least 3 years Secondary Endpoints: 1.A) Mean change over baseline of immune cell populations, cellular transcript and protein expression, and cytokine levels in peripheral blood and mucosal tissue across at least 3 study visits during a two-year period. 1.B) Assessment of disease activity (endoscopic evaluation, and histopathology) at each endoscopy and evaluation of progression of disease activity across at least 3 endoscopies during a two-year period. If a treatment is implemented, then disease activity will be assessed and compared over consecutive endoscopies. 1. C) Identification of molecular patterns or immune signatures that correlate with disease activity and response to treatment 2. A) Quantification of gene expression data and its trajectory over the course of disease and after therapy 2.B) Establishment of positive or negative correlation between candidate susceptible genes and disease phenotype 3.A) To establish positive or negative correlations between specific food components and nutrient amounts with disease activity obtained from questionnaires over 12 months 3.B) to establish correlations with nutritional data and the microbiome over 12 months
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
