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Functional Gastrointestinal Disorders in Pediatric IBD

NCT03565263 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2020-11-17

No results posted yet for this study

Summary

Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.

Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.

Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.

Conditions

  • Inflammatory Bowel Diseases
  • Functional Gastrointestinal Disorders
  • Pediatric Disorder
  • Anxiety Depression
  • Quality of Life

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Claire Dupont-Lucas · Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2019-02-08
Completion
2020-11-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565263 on ClinicalTrials.gov