Tissue Cytomegalovirus Viral Load and Associated Factors in Pediatric Patients Undergoing Colonoscopy

NCT07419204 | Completed DMC

• 2 other identifiers: GaziUDGazi University
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and Objectives Patients diagnosed with Inflammatory Bowel Disease (IBD) carry a significantly elevated risk for opportunistic infections and the reactivation of latent pathogens, most notably Cytomegalovirus (CMV). CMV reactivation in the colonic mucosa can exacerbate underlying IBD, leading to poor clinical outcomes and resistance to standard immunosuppressive therapies. This prospective study was designed with a multi-faceted objective: To evaluate and quantify the CMV viral load within the intestinal tissues of a pediatric cohort, comprising both IBD and non-IBD control groups. To identify specific clinical and biological factors associated with increased CMV detection. To establish potential diagnostic threshold values for CMV viral load in the colonic mucosa, with a primary focus on Ulcerative Colitis (UC) patients-where CMV colitis is most prevalent-as well as patients with other intestinal pathologies. To perform a comparative analysis of diagnostic modalities, specifically evaluating the diagnostic value of histopathology, serum Cytomegalovirus-Polymerase Chain Reaction (CMV-PCR), and tissue CMV-PCR. 2\. Methodology and Procedural Framework The research was conducted at the Pediatric Gastroenterology Endoscopy Unit between May 2022 and March 2024. The study population consisted of pediatric patients undergoing scheduled colonoscopies. Biopsy Protocol: During the endoscopic procedure, two biopsy samples were systematically obtained from the rectal mucosa. For patients presenting with mucosal ulcers, samples were extracted directly from the ulcerated site; in patients with macroscopically normal mucosa, samples were taken from standard rectal tissue. Contamination Prevention: To ensure molecular integrity and prevent cross-contamination, separate forceps were utilized for samples intended for PCR analysis versus those intended for histopathology. Laboratory Analysis: Concurrently, venous blood samples were collected to analyze CMV serology (anti-CMV Immunoglobulin G \[IgG\] / Immunoglobulin M \[IgM\]) and serum CMV-PCR. In cases of IgM positivity, CMV IgG avidity tests were performed to distinguish between primary infection and reactivation. Diagnostic Criteria: A diagnosis of CMV colitis was established based on clinical symptoms, histopathological evidence (Hematoxylin and Eosin \[HE\] staining and Immunohistochemistry \[IHC\]), and a serum CMV-PCR threshold of ≥1000 copies/mL. 3\. Molecular and Histopathological Techniques Deoxyribonucleic Acid (DNA) Extraction: Tissue DNA was extracted using the QIAamp DNA Mini Kit, involving overnight incubation at 56°C for complete tissue digestion. Plasma DNA extraction was automated via the QIAsymphony SP platform. Internal controls were used in every run to validate extraction efficiency. Real-Time Polymerase Chain Reaction (Real-Time PCR): Amplification targeted a 105-bp region of the CMV genome using the Artus CMV QS-RGQ Kit. The assay provided a wide linear range (79.4 to 1×10⁸ copies/mL) with a high analytical sensitivity of 42.5 copies/mL. Results were reported as copies/mL for blood and copies/mg for tissue. Immunohistochemistry (IHC): Four-micrometer tissue sections were analyzed for CMV expression using the Ventana Benchmark XT platform. Nuclear staining was the primary indicator for CMV positivity, with known positive colon mucosa serving as the control. 4\. Statistical Analysis Data were analyzed using IBM SPSS Statistics Version 20.0. The normality of the data was verified using Shapiro-Wilk tests and visualization tools (histograms and Q-Q plots). Comparative Statistics: Categorical variables were assessed via Chi-square tests. Continuous variables were analyzed using Student's t-test (parametric) or the Mann-Whitney U test (non-parametric). Correlations: Relationships between viral loads and clinical variables were evaluated using Spearman's correlation and point-biserial correlation. A p-value of \<0.05 was maintained as the threshold of statistical significance.

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Colonoscopy; CMV

Keywords

inflammatory bowel disease; Crohn's disease; Ulcerative colitis; CMV; histopathology; PCR

Outcome Measures

Primary Outcomes (1)

• Tissue and serum CMV Viral Load

  Cytomegalovirus Polymerase chain reaction levels were detected in both blood and tissue samples across the entire patient population

  1,5 year

Other Outcomes (1)

• Comparison of diagnostic methods for CMV colitis

  1,5 year

Study Arms (1)

The patients who underwent colonoscopy at the Pediatric Gastroenterology Department.

Biopsy specimens were obtained from the intestinal mucosa of pediatric patients who underwent colonoscopy for any clinical indication within the specified period.

Diagnostic Test: Colonoscopy after bowel cleansing

Interventions

Colonoscopy after bowel cleansing DIAGNOSTIC_TEST

This is the first prospective study to concurrently examine and compare CMV PCR levels in colonic tissue and associated histopathological changes between pediatric patients with and without Inflammatory Bowel Disease (IBD)

Also known as: polymerase chain reaction, CMV histopathology

The patients who underwent colonoscopy at the Pediatric Gastroenterology Department.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population: Pediatric patients who underwent colonoscopic evaluation at the Pediatric Gastroenterology Endoscopy Unit between May 2022 and March 2024.

You may not qualify if:

• Patients with insufficient bowel preparation for a high-quality colonoscopic examination.
• Biopsy Contraindications: Individuals with medical conditions precluding biopsy, such as bleeding diathesis.
• Non-Participation: Patients or guardians who declined to participate in the study.
• Children who were undergoing treatment for CMV disease
• Children who were receiving antiviral therapy (e.g. acyclovir)

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Odul OE Egritas Gurkan, Professor

  Gazi Universty Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: May 2, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 2026-2030
• Access Criteria: De-identified individual participant data and supporting clinical documents (such as the study protocol) will be made available to qualified researchers upon reasonable request. Access will be granted following a review of the research proposal by the principal investigator and institutional ethics committee to ensure data privacy and methodological soundness. Requests should be directed to the corresponding author via email.

Locations

TU (1)