- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07797998
Association of Diet and IBD
Association of Nutritional Status, Dietary Inflammatory Index, and Hematological Inflammatory Biomarkers With Disease Activity in Patients With Inflammatory Bowel Disease.
Aperçu de l'étude
Statut
Description détaillée
The prevalence of inflammatory bowel diseases [IBD] has risen over the past decade to become a global concern. Malnutrition is one of the major issues in patients who suffer from IBD, including both CD and UC. In published studies, approximately three-quarters of patients with active IBD have protein-energy malnutrition . It is a serious concern because it links with a higher risk of infections, weak outcomes, poor prognosis, and bad post-surgical recovery . Nutrition status in IBD plays a vital role since it can alter disease activity and affect morbidity. Not only does malnutrition affect disease activity, but the dietary inflammatory potential of the diet also affects the progression and therapeutic success in IBD patients. The dietary inflammatory potential refers to the ability of a dietary pattern or specific foods to either promote or reduce inflammation in the body. Dietary components may have anti- or pro-inflammatory potentials, which can be evaluated with indices such as the Dietary Inflammatory Index (DII). DII stands out for its particular emphasis on the connection between food consumption and the development and aggravation of inflammation. Therefore, it seems sense to assess this relationship in IBD patients. There are, however, few research on the pro-inflammatory potential of diet as determined by dietary indicators and their influence on IBD activity, and the findings are equivocal.
Inflammation and abnormalities in the immune system appear to be a critical factor in the development of IBD. Therefore, noninvasive inflammatory biomarkers may help as a noninvasive, easier accessible way to detect IBD activity state than Colonoscopy, which is the most sensitive and specific diagnostic step for diagnosing and determining the disease activity and severity.
Complete blood count (CBC)-derived inflammatory indices are inexpensive, widely available mathematical formulas. They act as reliable, non-invasive proxy markers for systemic inflammation, disease activity, and immune function by tracking the balance between innate and adaptive immune cells Therefore, in our study, we aim to assess the effect of nutritional status on IBD activity and the role of inflammatory biomarkers as a simple method to determine disease activity.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gamal A Abd-Elbar, General Practitioner
- Numéro de téléphone: 201028953251
- E-mail: gamal.18313454@med.aun.edu.eg
Lieux d'étude
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Asyut, Egypte
- Assiut University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients aged 18-65 years.
- patients diagnosed with either Crohn's disease or ulcerative colititis
Exclusion Criteria:
- Patients with previously identified thyroid illness.
- Patients with acute infection.
- Patients with major surgeries or recent trauma within the last 6 months.
- Patients known to have a malignancy.
- Patient with a previous history of bariatric surgery.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.
Délai: baseline and up to one year
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Nutritional status is assessed using the Subjective Global Assessment (SGA) tool.
The scale categorizes patients from A (well-nourished) to C (severely malnourished).
A higher alphabetical category (C) indicates a worse nutritional outcome.
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baseline and up to one year
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Disease Activity Assessed by the Crohn's Disease Activity Index (CDAI)..
Délai: Baseline, Week 8, and Week 24
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Disease activity in Crohn's disease patients is evaluated using the Crohn's Disease Activity Index (CDAI).
The theoretical score ranges from 0 to 600.
Higher scores indicate a worse outcome (greater disease severity).
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Baseline, Week 8, and Week 24
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Disease Activity in Ulcerative Colitis.
Délai: Baseline, Week 8, and Week 24
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Disease activity in ulcerative colitis patients is evaluated using the Mayo Score.
The score ranges from 0 to 12. Higher scores indicate a worse outcome (greater disease severity).
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Baseline, Week 8, and Week 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.
Délai: Baseline, Week 8, and Week 24
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The correlation between the inflammatory potential of the diet and Crohn's disease activity will be evaluated.
Diet is assessed via the Dietary Inflammatory Index (DII) derived from a Food Frequency Questionnaire.
The DII is a continuous scale where higher scores indicate a more pro-inflammatory diet.
Disease activity is assessed via the CDAI (scale: 0-600, higher scores indicate a worse outcome).
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Baseline, Week 8, and Week 24
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IBD2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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