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Clinical trialNCT05781152RecruitingPhase 4Interventional

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

SponsorConnecticut Children's Medical CenterEnrollment900Crohn Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Stollery Children'S Hospital

    Edmonton, Alberta, Canada

    Hien Q. Huynh, MDMatthew Carroll, MD
    Recruiting
  • Children'S Hospital Western Ontario

    London, Ontario, Canada

    Eileen Crowley, MB BCh BAOIan Ross, MD, FRCPC
    Recruiting
  • Children'S Hospital of Eastern Ontario

    Ottawa, Ontario, Canada

    David Mack, MD
    Recruiting
  • Toronto Sickkids Hospital

    Toronto, Ontario, Canada

    Anne Griffiths, MDThomas Walters, MBBS, MSc
    Recruiting
United States
  • Phoenix Children'S Hospital

    Phoenix, Arizona, United States

    Elizabeth Hilow, MDPaula Tizzard, MD
    Recruiting
  • Cedars-Sinai

    Los Angeles, California, United States

    David Ziring, MDShervin Rabizadeh, MD, MBA
    Recruiting
  • Rady Children'S Hospital - San Diego and University of California, San Diego

    San Diego, California, United States

    Active, not recruiting
  • Ucsf Benioff Children'S Hospitals

    San Francisco, California, United States

    Melvin Heyman, MD, MPHSofia Verstraete, MD, MAS
    Recruiting
  • Connecticut Children'S Medical Center

    Hartford, Connecticut, United States

    Jeffrey S Hyams, MD →Victoria Grossi, DO
    Recruiting
  • Emory University

    Atlanta, Georgia, United States

    B. Joanna Niklinska-Schirtz, MDSubra Kugathasan, MD →
    Recruiting
  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, United States

    Marian Pfefferkorn, MDSteven Steiner, MD
    Recruiting
  • the Johns Hopkins Children'S Medical Center

    Baltimore, Maryland, United States

    Anthony Guerrerio, MD, PhDMaria Oliva-Hemker, MD
    Recruiting
  • Boston Children'S Hospital

    Boston, Massachusetts, United States

    Jodie Ouahed, MD, MMScScott Snapper, MD, PhD
    Recruiting
  • University of Michigan

    Ann Arbor, Michigan, United States

    G. Jennifer Lee, MDJeremy Adler, MD, MSc
    Recruiting
  • Goryeb Children'S Hospital/morristown Medical Center/atlantic Children'S Health

    Morristown, New Jersey, United States

    Oren Koslowe, MDPeter Wilmot, MD
    Recruiting
  • Cohen Children'S Medical Center of Ny

    Lake Success, New York, United States

    Benjamin Sahn, MDJames Markowitz, MD
    Recruiting
  • Columbia University Medical Center

    New York, New York, United States

    Joseph Picoraro, MDNeal LeLeiko, MD, PhD
    Recruiting
  • Levine Children'S

    Charlotte, North Carolina, United States

    Nathan Fleishman, MDTiffany Linville, MD
    Recruiting
  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

    Jasbir Dhaliwal, MDLee Denson, MD
    Recruiting
  • Uh/rainbow Babies and Children'S Hospital

    Cleveland, Ohio, United States

    Denise Young, MDThomas Sferra, MD
    Recruiting
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Brendan Boyle, MD, MPHHilary Michel, MD
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Lindsey Albenberg, DORobert Baldassano, MD
    Recruiting
  • Upmc Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States

    Whitney Sunseri, MD
    Recruiting
  • Rhode Island Hospital

    Providence, Rhode Island, United States

    Jason Shapiro, MDShova Subedi, MD
    Recruiting
  • Seattle Children'S Hospital

    Seattle, Washington, United States

    David Suskind, MDHengqi (Betty) Zheng, MD
    Recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

    Abdul Elkadri, MDJose Cabrera, MDJoshua Noe, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Anti-TNF therapy
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
10 Jun 2023
Primary completion
1 Jul 2028
Completion
1 Jul 2029
Last update posted
27 May 2026
Registered enrollment
900
Registry id
NCT05781152

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.