Early Changes in Inflammatory Indices and Healing in IBD

NCT07855055 | Not Yet Recruiting

• 1 other identifier: IBD-Indices-Assiut-2026
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crohn Disease; Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

Inflammatory bowel disease; Neutrophil-to-lymphocyte ratio; C-reactive protein; Endoscopic healing; Assiut

Outcome Measures

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.

  12 to 16 weeks

Secondary Outcomes (7)

• Proportion of patients with histological healing

  12 to 16 weeks

• Mean change in neutrophil-to-lymphocyte ratio

  Baseline and at 4 weeks

• Mean change in C-reactive protein

  Baseline and at 4 weeks

• Mean change in CRP-to-albumin ratio

  Baseline and at 4 weeks

• Mean change in systemic immune-inflammation index

  Baseline and at 4 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Mohamed Z Hagez, prof

  Internal Medicine Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Yehia M Alaa, Resident

CONTACT

01552751879; Yehia.18313599@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Internal Medicine

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share