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Recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT05781152

Public ClinicalTrials.gov record NCT05781152. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05781152
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
900 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 9, 2023
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029
Last update posted
May 26, 2026

2023 – 2029

United States locations

U.S. sites
22
U.S. states
16
U.S. cities
22
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 Recruiting
Cedars-Sinai Los Angeles California 90048 Recruiting
Rady Children's Hospital - San Diego and University of California, San Diego San Diego California 92123 Active, not recruiting
UCSF Benioff Children's Hospitals San Francisco California 94158 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Emory University Atlanta Georgia 30328 Recruiting
Riley Hospital for Children at Indiana University Health Indianapolis Indiana 46202 Recruiting
The Johns Hopkins Children's Medical Center Baltimore Maryland 21287 Recruiting
Boston Children's Hospital Boston Massachusetts 02115 Recruiting
University of Michigan Ann Arbor Michigan 48109 Recruiting
Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health Morristown New Jersey 07960 Recruiting
Cohen Children's Medical Center of NY Lake Success New York 11042 Recruiting
Columbia University Medical Center New York New York 10032 Recruiting
Levine Children's Charlotte North Carolina 28203 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
UH/Rainbow Babies and Children's Hospital Cleveland Ohio 44106 Recruiting
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19146 Recruiting
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 Recruiting
Rhode Island Hospital Providence Rhode Island 02903 Recruiting
Seattle Children's Hospital Seattle Washington 98105 Recruiting
Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05781152, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 26, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05781152 live on ClinicalTrials.gov.

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