Functional Gastrointestinal Disorders in Pediatric IBD

Completed

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

• Registration Number: NCT03565263
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-09
• Study Start: 2018-04-03
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-21
• Primary Completion: 2019-02-08
• Status Verified: 2020-11
• Study Completion: 2020-11-08
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Functional Gastrointestinal Disorder	baseline	Rome III criteria for FGID (Fr-qPGS questionnaire)

Secondary Outcome Measures

Name	Time	Method
Depression (parents)	baseline	BDI questionnaire
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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France