- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gamal A Abd-Elbar, General Practitioner
- Número de teléfono: 201028953251
- Correo electrónico: gamal.18313454@med.aun.edu.eg
Ubicaciones de estudio
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Asyut, Egipto
- Assiut University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.
Periodo de tiempo: 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)..
Periodo de tiempo: 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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IBD2026
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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