Trials / Completed
CompletedNCT03565263
Functional Gastrointestinal Disorders in Pediatric IBD
Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 350 (actual)
- Sponsor
- University Hospital, Caen · Academic / Other
- Sex
- All
- Age
- 9 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2019-02-08
- Completion
- 2020-11-08
- First posted
- 2018-06-21
- Last updated
- 2020-11-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03565263. Inclusion in this directory is not an endorsement.