Clinical Trial on IBD, Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Gamal A Abd-Elbar, General Practitioner
Phone Number: 201028953251
Email: gamal.18313454@med.aun.edu.eg

Study Locations

Egypt
- - Asyut, Egypt
    - Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study include People with IBD from Egypt

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and up to one year
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).	Baseline, Week 8, and Week 24
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).	Baseline, Week 8, and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 8, and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 29, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)