Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease

What this study is about

Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.

Who can join (things the study team will check)

Phase 1 Inclusion Criteria 1. Age ≥ 6 years and \< 18 years at enrollment 2. Suspected diagnosis of CD 3. Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin. 4. Parent/guardian consent and patient assent 5. Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy Phase 1 Exclusion Criteria 1. Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation 2. Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture) 3. Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma) 4. Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampli…

Where this trial is running

• Phoenix Children's Hospital, Phoenix, Arizona, United States
• Cedars-Sinai, Los Angeles, California, United States
• Rady Children's Hospital - San Diego and University of California, San Diego, San Diego, California, United States
• UCSF Benioff Children's Hospitals, San Francisco, California, United States
• Connecticut Children's Medical Center, Hartford, Connecticut, United States
• Emory University, Atlanta, Georgia, United States
• Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States
• The Johns Hopkins Children's Medical Center, Baltimore, Maryland, United States
• Boston Children's Hospital, Boston, Massachusetts, United States
• University of Michigan, Ann Arbor, Michigan, United States
• Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health, Morristown, New Jersey, United States
• Cohen Children's Medical Center of NY, Lake Success, New York, United States

+ 14 more sites.

Who to contact

Dena E Hopkins, MPH, CCRP · 860-545-8125 · CAMEO_CCC@connecticutchildrens.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05781152.