- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03565263
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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Caen, Frankrike
- CAEN University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
---|
FGID-IBD
|
No FGID-IBD
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Presence of Functional Gastrointestinal Disorder
Tidsramme: baseline
|
Rome III criteria for FGID (Fr-qPGS questionnaire)
|
baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Anxiety
Tidsramme: baseline
|
SCARED-R questionnaire
|
baseline
|
Depression
Tidsramme: baseline
|
CDI questionnaire
|
baseline
|
Quality of life - disease related
Tidsramme: baseline
|
IMPACT-III questionnaire
|
baseline
|
Fatigue
Tidsramme: baseline
|
peds FACIT-F questionnaire
|
baseline
|
Anxiety (parents)
Tidsramme: baseline
|
STAI/Y-A and STAI/Y-B questionnaires
|
baseline
|
Depression (parents)
Tidsramme: baseline
|
BDI questionnaire
|
baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Claire Dupont-Lucas, Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives pediatriques
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17-160
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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