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NCT Number: NCT07797998

Association of Diet and IBD

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.

    Time frame: 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.

  2. Disease Activity Assessed by the Crohn's Disease Activity Index (CDAI)..

    Time frame: 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).

  3. Disease Activity in Ulcerative Colitis.

    Time frame: 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).

Secondary outcomes

  1. Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gamal A Abd-Elbar, General Practitioner

CONTACT

[email protected]

201028953251

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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