Skip to content

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02392221
Acronym
Inspired
Enrollment
966
Registered
2015-03-18
Start date
2015-05-01
Completion date
2019-04-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Inflammatory Bowel Disease

Keywords

Crohn's disease (CD), Pediatric, Inflammatory Bowel Disease

Brief summary

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

Detailed description

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p \<0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population. The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER
Funding from DGOS (PHRC IR 2013 and PRME)
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 26 Years
Healthy volunteers
No

Inclusion criteria

Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Cumulative incidence of surgical resection in CD and colectomy in pediatric UCend of follow upCumulative incidence of surgical resection in CD and colectomy in pediatric ulcerative colitis, depending on the date of diagnosis and the possibility of using immunosuppressants and / or anti-TNFs.

Secondary

MeasureTime frameDescription
Disease extension according to Montreal classificationend of follow upPhenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis
Treatment during the follow upend of follow uptreatment
information about occurrence of postoperative complicationsend of follow upPresence, date and type of occurrence of postoperative complications (Dindo classification).
Weight and sizeend of follow upWeight and size at diagnosis, at the first intestinal resection and at the end of follow up
Hospitalisationsend of follow upnumber, duration, date
Studies category Socio-Professionalend of follow upStudies category Socio-Professional (CSP) and occupation
Age of pubertyend of follow upAge of puberty
Deathend of follow upDeath and if so; due date and
Complicationsend of follow upSerious infectious complications and cancer
cost-effectiveness evalutation of different management strategies of IBDend of follow upcost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients
Variation of cost-effectiveness ratio of IBD treatment strategiesat 5 yearsVariation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.
Variation of cost-utility ratio of IBD treatment strategiesat 15 yearsVariation of cost-utility ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.

Countries

France

Contacts

STUDY_DIRECTORMathurin Fumery, Doctor

CHU Amiens France

STUDY_DIRECTORJean-Louis Dupas, professor

CHU Amiens France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026