Functional Gastrointestinal Disorders in Pediatric IBD (TFI-MICI)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In the aim of recruiting a sample that will be the most representative possible of the population of pediatric IBD patients in remission in France, patients will be recruited for the study through different procedures:

• either during a routine visit to the pediatric gastroenterology clinic (all French pediatric gastroenterology clinics will be study centers)
• or during a routine visit to the adult gastroenterology clinic (the French adult gastroenterologists will be informed of the study and will be able to apply to be a study center)
• finally, the patient will be able to find information on the study through the French IBD patient Foundation (association Francois Aupetit) and contact the investigators in order to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Claire Dupont-Lucas, Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): November 8, 2020

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Gastroenteritis; Disease; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: 17-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No