Clinical trial NCT03565263: Functional Gastrointestinal Disorders in Pediatric IBD
Official title: Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Functional Gastrointestinal Disorders
Pediatric Disorder
Anxiety Depression
Quality of Life
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 350
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In the aim of recruiting a sample that will be the most representative possible of the population of pediatric IBD patients in remission in France, patients will be recruited for the study through different procedures:

* either during a routine visit to the pediatric gastroenterology clinic (all French pediatric gastroenterology clinics will be study centers)
* or during a routine visit to the adult gastroenterology clinic (the French adult gastroenterologists will be informed of the study and will be able to apply to be a study center)
* finally, the patient will be able to find information on the study through the French IBD patient Foundation (association Francois Aupetit) and contact the investigators in order to participate.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* IBD (Crohns disease, Ulcerative colitis or IBD-U)
* in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, \< or = 3 stools/day, C reactive protein \< 10 mg/L, erythrocyte sedimentation rate \< 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
* followed for IBD for at least 1 year

Exclusion Criteria:

* presence of an ileostomy or colostomy
* past history of total colectomy
* unable to understand written French or to answer the questionnaires

Primary outcomes:
measure: Presence of Functional Gastrointestinal Disorder
timeFrame: baseline
Secondary outcomes:
measure: Anxiety
timeFrame: baseline
measure: Depression
timeFrame: baseline
measure: Quality of life - disease related
timeFrame: baseline
measure: Fatigue
timeFrame: baseline
measure: Anxiety (parents)
timeFrame: baseline
measure: Depression (parents)
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques
name: Claire Dupont-Lucas
role: PRINCIPAL_INVESTIGATOR
References: