Microbiome and Genetic Profile [MGP] of Very Early-Onset Pediatric Inflammatory Bowel Disease and Pediatric Inflammatory Bowel Disease

Study Details

Utilization of Microbiota and Genetic Profile to Provide Targeted Management to Very-Early-Onset Pediatric Inflammatory Bowel and Pediatric Inflammatory Bowel Disease in a Tertiary Center in South Florida

Conditions:

Very Early-Onset Irritable Bowel Syndrome, IBD, VEO-IBD

Study ID

GAS23122

Study Description

Pediatric IBD is a chronic immune-mediated disease that affects the gastrointestinal tract. The incidence of pediatric IBD is approximately 10 per 100,000 children in the United States and rising. Furthermore, IBD presenting in children less than six years of age is known as very early-onset IBD (VEO-IBD), accounting for 6-15% of pediatric IBD cases. NCH aims to understand the genetic makeup of IBD within South Florida and support personalized diagnoses and treatment for NCH pediatric patients and their families.

Eligibility Requirements

Inclusion Criteria

  1. Children and adolescents between 0 months and 20 years old
  2. Diagnosis of Ulcerative Colitis or Crohn’s Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and gastrointestinal histology.
  3. Mild, moderate, or severe disease activity based on PCDAI score and PUCAI score.
  4. Parent/guardian and the patient must be able to comprehend the consent and assent.
  5. Parent/guardian and the patient must be able to attend study visits at baseline and weeks +12, +26, +52, and +72.
  6. Patient must not have medication changes for his/her IBD medications for at least 1 month before study enrollment unless medically necessary.

Exclusion Criteria

  1. Has had a change of maintenance medication within the last month.
  2. Engages in tobacco, alcohol, or illicit drug abuse.
  3. Is pregnant.

Principal Investigator

Lina Maria Felipez, MD

Associate Medical Director, Inflammatory Bowel Disease (IBD) Center Director, IBD Research

More Information: Miami Beach

Clinical Interests:
Inflammatory Bowel Disease (IBD), reflux, constipation, celiac disease, eosinophilic esophagitis

This page was last updated on: 4/24/2026 9:07:16 AM