Functional Gastrointestinal Disorders in Pediatric IBD

Overview

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.

Full Title of Study: “Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: February 8, 2019

Arms, Groups and Cohorts

  • FGID-IBD
    • 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
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Presence of Functional Gastrointestinal Disorder
    • Time Frame: baseline
    • Rome III criteria for FGID (Fr-qPGS questionnaire)

Secondary Measures

  • Anxiety
    • Time Frame: baseline
    • SCARED-R questionnaire
  • Depression
    • Time Frame: baseline
    • CDI questionnaire
  • Quality of life – disease related
    • Time Frame: baseline
    • IMPACT-III questionnaire
  • Fatigue
    • Time Frame: baseline
    • peds FACIT-F questionnaire
  • Anxiety (parents)
    • Time Frame: baseline
    • STAI/Y-A and STAI/Y-B questionnaires
  • Depression (parents)
    • Time Frame: baseline
    • BDI questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 9 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Caen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Claire Dupont-Lucas, Principal Investigator, Groupe d’Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

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