Functional Gastrointestinal Disorders in Pediatric IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-03

Study Completion Date

2020-11-08

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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 interventions assigned to this group

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)

No interventions assigned to this group

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Dupont-Lucas

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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17-160

Identifier Type: -

Identifier Source: org_study_id