ClinicalTrials.gg
Not yet recruitingNCT07797998Updated Sep 1, 2026

Association of Diet and IBD

An observational study in IBD and Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Primary conditionColitis, UlcerativeRegistry: Inflammatory Bowel DiseasesReclassifiedWhy we changed it
Registry
Inflammatory Bowel Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Colitis, Ulcerative
Why
  1. The study's listed conditions name Colitis, Ulcerative, a narrower term within Inflammatory Bowel Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Colitis, Ulcerative by Assiut University — 12 open to participants now, 12 under way, none of them phase 3. Colitis, Ulcerative · Assiut University.

Planned enrollment
7th of 17
100 · median 100
Started
2026
with 6 others
Observational
17 of 18
12 open now
Primary completion
2028-01
later than 11 of 11 live
Registered
15th of 18
by date

Among the 18 studies in Colitis, Ulcerative by Assiut University, this one is the 7th largest by planned enrollment of the 17 observational ones that give a count, is one of 7 that started in 2026, is one of 17 observational ones, reaches primary completion later than 11 of the 11 other live ones, and was the 15th registered.

Colitis, Ulcerative

1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.

Browse Colitis, Ulcerative studies →

Open to participants now

12 of the 18 studies in Colitis, Ulcerative by Assiut University are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • IBD
  • Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Browse trials for

Keywords

  • Diet inflammation index
  • ibd
  • nutritional status
  • Hematological Inflammatory Biomarkers
  • disease activity
04

In context

Colitis, Ulcerative Reclassified

1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.

This study's planned enrollment of 100 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Colitis, Ulcerative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammatory Bowel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study include People with IBD from Egypt

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 .
  • Patient with a previous history of bariatric surgery.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and up to one year

  2. 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).

    Time frame: Baseline, Week 8, and Week 24

  3. 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).

    Time frame: 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).

    Time frame: Baseline, Week 8, and Week 24

08

Study locations

1 site
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Sep 1, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Oct 1, 2028
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07797998
Lead sponsor
Assiut University
Responsible party
Gamal Abd-Elnaser Abd-Elbar Osman (assistan lecturer, Assiut University) — Principal investigator
First posted
Sep 1, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Gamal A Abd-Elbar, General Practitioner
Contact
gamal.18313454@med.aun.edu.eg
201028953251

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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