IBDNCT07797998
Association of Diet and IBD
An observational study of IBD and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Assiut University at 1 site in Egypt.
Trial summary
The study investigate the nutritional status and inflammatory markers and diet inflammatory index in patients with IBD and their effect on disease activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBD, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study include People with IBD from Egypt
Who may be able to join
- Patients aged 18-65 years.
- patients diagnosed with either Crohn's disease or ulcerative colititis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Diet inflammation index, ibd, nutritional status, Hematological Inflammatory Biomarkers, disease activity
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status Assessed by the Subjective Global Assessment (SGA) Score.
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.
Measured: baseline and up to one year
Disease Activity Assessed by the Crohn's Disease Activity Index (CDAI)..
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).
Measured: Baseline, Week 8, and Week 24
Disease Activity in Ulcerative Colitis.
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).
Measured: Baseline, Week 8, and Week 24
Secondary outcomes (1)
Pearson Correlation Coefficient Between Dietary Inflammatory Index (DII) Scores and disease activity in IBD Patients.
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).
Measured: Baseline, Week 8, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Abd-Elnaser Abd-Elbar Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797998
- Sponsor's protocol ID
- IBD2026
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No