Functional Gastrointestinal Disorders in Pediatric IBD

Study Overview
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Brief Summary
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FGID-IBD<br>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<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Functional Gastrointestinal Disorder | Rome III criteria for FGID (Fr-qPGS questionnaire) | baseline | 

Secondary Outcome Measures

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