Health TrialsbyHealthPanel

Early Changes in Inflammatory Indices and Healing in IBD

ConditionsInflammatory Bowel DiseaseUlcerative ColitisCrohn Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active infection

Recent major surgery

Malignancy

Hematological malignancy or disorder substantially altering leukocyte or platelet counts

Trial population

Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

138 Participants
are grouped into 1 trial group
Group A: Single cohort: Adult IBD Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
12 to 16 weeks

Secondary outcomes

1

Proportion of patients with histological healing

Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies.

Time frame
12 to 16 weeks
2

Mean change in neutrophil-to-lymphocyte ratio

Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks.

Time frame
Baseline and at 4 weeks
3

Mean change in C-reactive protein

Mean change in C-reactive protein (CRP) level from baseline to 4 weeks.

Time frame
Baseline and at 4 weeks
4

Mean change in CRP-to-albumin ratio

Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks.

Time frame
Baseline and at 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: