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Completed

NCT Number: NCT03565263

Functional Gastrointestinal Disorders in Pediatric IBD

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.

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Key information

Conditions

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

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of Functional Gastrointestinal Disorder

    Time frame: baseline

    Rome III criteria for FGID (Fr-qPGS questionnaire)

Secondary outcomes

  1. Anxiety

    Time frame: baseline

    SCARED-R questionnaire

  2. Depression

    Time frame: baseline

    CDI questionnaire

  3. Quality of life - disease related

    Time frame: baseline

    IMPACT-III questionnaire

  4. Fatigue

    Time frame: baseline

    peds FACIT-F questionnaire

  5. Anxiety (parents)

    Time frame: baseline

    STAI/Y-A and STAI/Y-B questionnaires

  6. Depression (parents)

    Time frame: baseline

    BDI questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: TFI-MICI

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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