Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Association of Diet and IBD

29. august 2026 opdateret af: Gamal Abd-Elnaser Abd-Elbar Osman, Assiut University

Association of Nutritional Status, Dietary Inflammatory Index, and Hematological Inflammatory Biomarkers With Disease Activity in Patients With Inflammatory Bowel Disease.

The study investigate the nutritional status and inflammatory markers and diet inflammatory index in patients with IBD and their effect on disease activity.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Asyut, Egypten
        • Assiut University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study include People with IBD from Egypt

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.
Tidsramme: baseline and up to one year
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.
baseline and up to one year
Disease Activity Assessed by the Crohn's Disease Activity Index (CDAI)..
Tidsramme: Baseline, Week 8, and Week 24
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).
Baseline, Week 8, and Week 24
Disease Activity in Ulcerative Colitis.
Tidsramme: Baseline, Week 8, and Week 24
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).
Baseline, Week 8, and Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.
Tidsramme: Baseline, Week 8, and Week 24
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).
Baseline, Week 8, and Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. oktober 2028

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

29. august 2026

Først opslået (Faktiske)

1. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Abonner