Functional Gastrointestinal Disorders in Pediatric IBD

NCT03565263 | Completed

• 1 other identifier: 17-160
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Presence of Functional Gastrointestinal Disorder

  Rome III criteria for FGID (Fr-qPGS questionnaire)

  baseline

Secondary Outcomes (6)

• Anxiety

  baseline

• Depression

  baseline

• Quality of life - disease related

  baseline

• Fatigue

  baseline

• Anxiety (parents)

  baseline

Study Arms (2)

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)

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• presence of an ileostomy or colostomy
• past history of total colectomy
• unable to understand written French or to answer the questionnaires

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Intestinal Diseases

Study Officials

• Claire Dupont-Lucas

  Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: June 21, 2018
• Study Start: April 3, 2018
• Primary Completion: February 8, 2019
• Study Completion: November 8, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)