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Completed

NCT Number: NCT07263477

A Study on the Relationship of Interleukin-7 Receptor Gene Polymorphisms With the Risk of Crohn's Disease Onset and the Efficacy of Infliximab

From January 2020 to May 2025, 303 CD patients and 514 normal controls were retrospectively collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the the relationship of interleukin-7 receptor (IL-7R) gene polymorphisms with the risk of Crohn's disease (CD) onset, the clinicopathological features of CD and the efficacy of infliximab (IFX) therapy.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

From January 2020 to May 2025, 303 CD patients and 514 normal controls were retrospectively collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the the relationship of interleukin-7 receptor (IL-7R) gene polymorphisms with the risk of Crohn's disease (CD) onset, the clinicopathological features of CD and the efficacy of infliximab (IFX) therapy. Multiple polymerase chain reaction ligase detection technology was used to detect the genotype of IL-7R (rs6897932, rs1494555, rs1494558). According to the Montreal CD classification criteria, patients were divided into different subgroups. The Crohn's Disease Activity Index (CDAI) is used to evaluate clinical activity, while the Simplified Crohn's Disease Endoscopic Score (SES-CD) is used to assess endoscopic activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion criteria

  • rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Treatment and study plan

Infliximab

Biological

Intravenous injection of IFX (5mg/kg) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of IFX every 8 weeks to maintain treatment.

Primary outcomes

  1. Genotypes of IL-7R

    Time frame: Baseline

    multiplex polymerase chain reaction-ligase detection reaction technique

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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