Functional Gastrointestinal Disorders in Pediatric IBD (TFI-MICI)

Caen University Hospital

Status: Completed

Conditions: Anxiety Depression; Pediatric Disorder; Functional Gastrointestinal Disorders; Quality of Life; Inflammatory Bowel Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT03565263

17-160

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

FGID-IBD

Description:

* Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * 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 * with at least one Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)

No FGID-IBD

Description:

* Patients aged 9-18 years * with inflammatory bowel disease (Crohns, ulcerative colitis or indeterminate colitis) * 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 * not a single Functional Gastrointestinal disorder according to the Fr-qPGS questionnaire (Rome III criteria)