- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Gamal A Abd-Elbar, General Practitioner
- Telefonnummer: 201028953251
- E-post: gamal.18313454@med.aun.edu.eg
Studiesteder
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Asyut, Egypt
- Assiut University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.
Tidsramme: 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)..
Tidsramme: 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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IBD2026
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