Inflammatory Bowel DiseaseNCT07855055
Early Changes in Inflammatory Indices and Healing in IBD
An observational study of Inflammatory Bowel Disease and Ulcerative Colitis, run by Assiut University.
Trial summary
This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 10 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
Who may be able to join
- Age 18 years or older
- Confirmed diagnosis of ulcerative colitis or Crohn's disease
- Objective evidence of active disease at baseline
- Planned initiation or escalation of IBD treatment
- Baseline CBC with differential, CRP, and serum albumin available
- Planned follow-up assessment at approximately 12-16 weeks
- Planned follow-up colonoscopy with mucosal biopsies at approximately 12-16 weeks
- Written informed consent
Who cannot join
- Active infection
- Recent major surgery
- Malignancy
- Hematological malignancy or disorder substantially altering leukocyte or platelet counts
- Significant uncontrolled liver disease
- Severe renal disease expected to substantially affect inflammatory markers
Show all 12Show fewer
- Recent blood transfusion
- Pregnancy
- Concomitant autoimmune inflammatory disease
- Systemic corticosteroids used for another indication
- Acute severe infection around the time of blood sampling
- Inadequate follow-up or missing essential data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease
This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.
Read the detailed description
Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.
Blood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.
- Keywords
- Inflammatory bowel disease, Neutrophil-to-lymphocyte ratio, C-reactive protein, Endoscopic healing, Assiut
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Adult IBD Patients | Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with endoscopic healing
Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD < 3 in Crohn's disease.
Measured: 12 to 16 weeks
Secondary outcomes (7)
Proportion of patients with histological healing
Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies.
Measured: 12 to 16 weeks
Mean change in neutrophil-to-lymphocyte ratio
Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks.
Measured: Baseline and at 4 weeks
Mean change in C-reactive protein
Mean change in C-reactive protein (CRP) level from baseline to 4 weeks.
Measured: Baseline and at 4 weeks
Mean change in CRP-to-albumin ratio
Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks.
Measured: Baseline and at 4 weeks
Mean change in systemic immune-inflammation index
Mean change in systemic immune-inflammation index (SII) from baseline to 4 weeks.
Measured: Baseline and at 4 weeks
Mean Mayo Endoscopic Score
Mean Mayo Endoscopic Score in patients with ulcerative colitis (range 0-3, higher scores indicate more severe endoscopic activity).
Measured: 12 to 16 weeks
Mean SES-CD score
Mean Simple Endoscopic Score for Crohn's Disease (SES-CD) (higher scores indicate more severe endoscopic activity).
Measured: 12 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Mohamed alaa aldin saad ali, Assiut University
- Investigators
- Mohamed Z Hagez, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855055
- Sponsor's protocol ID
- IBD-Indices-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07855055
- Acronym / sponsor ID
- IBD-Indices-Assiut-2026
- Keywords
- Inflammatory bowel disease, Neutrophil-to-lymphocyte ratio, C-reactive protein, Endoscopic healing, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.
Detailed description
Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.
Blood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Adult IBD Patients | – | –Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
Key inclusion criteria (8 listed)
- Age 18 years or older
- Confirmed diagnosis of ulcerative colitis or Crohn's disease
- Objective evidence of active disease at baseline
- Planned initiation or escalation of IBD treatment
- Baseline CBC with differential, CRP, and serum albumin available
Key exclusion criteria (12 listed)
- Active infection
- Recent major surgery
- Malignancy
- Hematological malignancy or disorder substantially altering leukocyte or platelet counts
- Significant uncontrolled liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with endoscopic healing
Time frame: 12 to 16 weeks
Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD < 3 in Crohn's disease.
7 secondary outcomes
Proportion of patients with histological healing
Time frame: 12 to 16 weeks
Mean change in neutrophil-to-lymphocyte ratio
Time frame: Baseline and at 4 weeks
Mean change in C-reactive protein
Time frame: Baseline and at 4 weeks
Mean change in CRP-to-albumin ratio
Time frame: Baseline and at 4 weeks
Mean change in systemic immune-inflammation index
Time frame: Baseline and at 4 weeks
Mean Mayo Endoscopic Score
Time frame: 12 to 16 weeks
Mean SES-CD score
Time frame: 12 to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Z Hagez, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Ulcerative Colitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehia M Alaa, Resident (01552751879, Yehia.18313599@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with endoscopic healing (time frame: 12 to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.