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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Caen、フランス
- Caen University hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースコントロール
- 時間の展望：断面図
コホートと介入
グループ/コホート |
|---|
|
FGID-IBD
|
|
No FGID-IBD
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of Functional Gastrointestinal Disorder
時間枠：baseline
|
Rome III criteria for FGID (Fr-qPGS questionnaire)
|
baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety
時間枠：baseline
|
SCARED-R questionnaire
|
baseline
|
|
Depression
時間枠：baseline
|
CDI questionnaire
|
baseline
|
|
Quality of life - disease related
時間枠：baseline
|
IMPACT-III questionnaire
|
baseline
|
|
Fatigue
時間枠：baseline
|
peds FACIT-F questionnaire
|
baseline
|
|
Anxiety (parents)
時間枠：baseline
|
STAI/Y-A and STAI/Y-B questionnaires
|
baseline
|
|
Depression (parents)
時間枠：baseline
|
BDI questionnaire
|
baseline
|
協力者と研究者
捜査官
- 主任研究者：Claire Dupont-Lucas、Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。