NCT07797998

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 24, 2026

Last Update Submit

August 29, 2026

Conditions

Keywords

Diet inflammation indexibdnutritional statusHematological Inflammatory Biomarkersdisease activity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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).

    Baseline, Week 8, and Week 24

Secondary Outcomes (1)

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

    Baseline, Week 8, and Week 24

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study include People with IBD from Egypt

You may qualify if:

  • Patients aged 18-65 years.
  • patients diagnosed with either Crohn's disease or ulcerative colititis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesColonic Diseases, Functional

Central Study Contacts

Gamal A Abd-Elbar, General Practitioner

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistan lecturer

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations