- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01756963
Diet and Disease Activity in Patients With Inflammatory Bowel Disease
In addition to a genetic susceptibility, the immune system and the intestinal microbiota, diet is hypothesized to be an important factor in the onset and progression of Inflammatory Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to targeted interventions improving disease burden and healthcare costs for these patients. However, well-designed studies exploring the role of diet in the development of exacerbations are hardly available.
The investigators hypothesize that differences in dietary patterns affects the intestinal microbiota composition and thereby contributes to the development of exacerbations in IBD.
Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence is unknown since simple noninvasive screening tools have not been validated for IBD. The investigators hypothesize that malnutrition is frequently present in IBD patients and associated with dietary intake and disease characteristics.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Limburg
-
Maastricht, Limburg, Holland
- Maastricht University Medical Center, Division of Gastroenterology/Hepatology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
- participating IBD-SL cohort
Exclusion Criteria:
- Unable to provide informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
---|
IBD-SL cohort
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To characterize intestinal microbiota in IBD patients with different dietary patterns
Tidsramme: 2 years
|
2 years
|
|
To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up
Tidsramme: 2 years
|
2 years
|
|
To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up
Tidsramme: 2 years
|
2 years
|
|
To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients
Tidsramme: 1 year
|
In a subpopulation of the present cohort (n=300) the nutritional status will be investigated
|
1 year
|
The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients
Tidsramme: 1 year
|
1 year
|
|
To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: M. Pierik, MD. PhD., Maastricht University Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NL 42101.068.12
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Inflammatorisk tarmsygdom
-
Arkansas Children's Hospital Research InstituteEunice Kennedy Shriver National Institute of Child Health and Human Development...AfsluttetSIRS (Systemic Inflammatory Response Syndrome)Forenede Stater
-
Chinese PLA General HospitalAfsluttetSepsis | SIRS (Systemic Inflammatory Response Syndrome)Kina
-
Chinese PLA General HospitalUkendtSepsis | SIRS (Systemic Inflammatory Response Syndrome)Kina
-
University of ArkansasAfsluttetPædiatriske patienter med SIRS (Systemic Inflammatory Response Syndrome)Forenede Stater
-
Hacettepe UniversityAfsluttetKolorektal cancer | Ammende | Koloskopi forberedelse | Boston Bowel Preparation ScaleKalkun
-
Seoul National University HospitalUkendtSund og rask | Kronisk forstoppelse | Constipated Irritable Bowel Syndrome
-
Seoul National University Boramae HospitalDong-A ST Co., Ltd.Ikke rekrutterer endnuSlidgigt | Rheumatoid arthritis | Enteritis | Mavesår | Ankyloserende spondylitis | Anden muskuloskeletal lidelse | NSAID-associeret gastropati | NSAID (Non-Steroidal Anti-inflammatory Drug) Induceret Enteropati