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Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
NCT05781152 · View on ClinicalTrials.gov ↗
Study 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 w
Conditions Studied
Interventions
- DRUG Anti-TNF therapy
Study Locations (20)
California
- Cedars-Sinai — Los Angeles
- Rady Children's Hospital - San Diego and University of California, San Diego — San Diego
- UCSF Benioff Children's Hospitals — San Francisco
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- UH/Rainbow Babies and Children's Hospital — Cleveland
- Nationwide Children's Hospital — Columbus
New York
- Cohen Children's Medical Center of NY — Lake Success
- Columbia University Medical Center — New York
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Arizona
- Phoenix Children's Hospital — Phoenix
Connecticut
- Connecticut Children's Medical Center — Hartford
Georgia
- Emory University — Atlanta
Indiana
- Riley Hospital for Children at Indiana University Health — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2023-06-10 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05781152
The ClinicalTrials.gov registry entry for NCT05781152 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Connecticut Children's Medical Center, which has 84 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention — of which Anti-TNF therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05781152 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Ohio, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05781152 about?
NCT05781152 is a clinical study titled "Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease". 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 o...
What is the current status of trial NCT05781152?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 900 participants. The study started on 2023-06-10. Estimated completion is 2029-07-01.
What conditions does trial NCT05781152 study?
This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05781152?
The interventions under investigation include: Anti-TNF therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05781152?
This trial is sponsored by Connecticut Children's Medical Center, which has 84 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05781152 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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