Functional Gastrointestinal Disorders in Pediatric IBD

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03565263

Acronym

TFI-MICI

Enrollment

350

Registered

2018-06-21

Start date

2018-04-03

Completion date

2020-11-08

Last updated

2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

9 Years to 18 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results