RecruitingPhase 4NCT05781152

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


Sponsor

Connecticut Children's Medical Center

Enrollment

900 participants

Start Date

Jun 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is following children who are newly suspected or diagnosed with Crohn's disease — a type of inflammatory bowel disease — to track how the disease progresses over time. Researchers will collect clinical, imaging, and endoscopy data over at least 12 months to better understand early disease patterns and outcomes. **You may be eligible if:** - You are at least 6 years old and under 18 years old - You are suspected of having Crohn's disease and are being evaluated - Stool tests, if performed, have come back negative for common infections - A parent or guardian is able to give consent, and you (the patient) are willing to assent to participation - You and your family can stay in follow-up for at least 12 months after initial evaluation **You may NOT be eligible if:** - You have a confirmed infection that may be mimicking Crohn's symptoms - You and your family are not able to commit to the follow-up schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-TNF therapy

Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool


Locations(26)

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

Columbia University Medical Center

New York, New York, United States

Levine Children's

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

UH/Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Seattle Children's Hospital

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Stollery Children's Hospital

Edmonton, Alberta, Canada

Children's Hospital Western Ontario

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Toronto SickKids Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05781152


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