Functional Gastrointestinal Disorders in Pediatric IBD

Quality of Life Clinical Trial

— TFI-MICI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565263
• Other study ID #: 17-160
• Status: Completed
• Start date: April 3, 2018
• Est. completion date: November 8, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 8, 2020
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• Digestive System Diseases
• Disease
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pediatric Disorder
• Quality of Life

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Functional Gastrointestinal Disorder	Rome III criteria for FGID (Fr-qPGS questionnaire)	baseline
Secondary	Anxiety	SCARED-R questionnaire	baseline
Secondary	Depression	CDI questionnaire	baseline
Secondary	Quality of life - disease related	IMPACT-III questionnaire	baseline
Secondary	Fatigue	peds FACIT-F questionnaire	baseline
Secondary	Anxiety (parents)	STAI/Y-A and STAI/Y-B questionnaires	baseline
Secondary	Depression (parents)	BDI questionnaire	baseline