Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment

Not yet recruiting

• Conditions: Predicting Biologic Therapy Response in Ulcerative Colitis Via Ultrasound and Visceral

• Registration Number: NCT07126015
• Lead Sponsor: Assiut University

Brief Summary

Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment

Detailed Description

Ulcerative colitis (UC) has a relapsing-remitting course which necessitates frequent follow-up examinations to monitor disease activity.

Disease management was previously guided by patient reported symptoms, and treatment targets were based on symptom control. However, the patient's symptoms do not necessarily correspond to inflammatory activity and current guidelines recommend that management should be based on objective evaluations.

Gastrointestinal ultrasound \[GIUS\] has high diagnostic accuracy for detecting active CD, and in trained hands, it can make significant impact on clinical decision-making.

Furthermore, as it is non-invasive, readily available and can be performed bedside, the modality seems well suited for bedside and frequent activity monitoring.

UC is often associated with underweight (BMI \< 18 kg/m2); however, numerous studies find overweight and obesity also common.

Patients were characterized by increased fat deposition and reduced skeletal muscles and theses patients are refractory to IBD treatment may have an increased risk of sarcopenic obesity.

Visceral adipose tissue (VAT) is the white adipose tissue surrounding the viscera, which can be divided into omental adipose tissue, mesenteric adipose tissue (MAT), retroperitoneal fat, peri-gonadal fat, and pericardial fat.

VAT releases inflammatory mediators, such as TNF-α, which are closely associated with inflammation. This suggests that VAT plays an inflammatory role in UC pathogenesis; arguably, VAT is one of the radiological markers.

One research found that VAT is associated with mucosal healing of anti-TNF therapy in Crohn's disease (CD). Studies demonstrated that a higher ratio of visceral to subcutaneous fat (SAT) (VAT:SAT) is linked to a shorter time to IBD flare-ups, including in ulcerative colitis.

Some research indicates that higher VAT levels might be associated with poorer responses to certain IBD treatments, potentially due to the inflammatory environment created by visceral fat.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Any patient above age of 18 years old and diagnosed to have active UC through
• Clinical features: rectal bleeding, with frequent stools and mucous discharge from the rectum. Some patients also describe tenesmus. The onset is typically insidious.
• Endoscopic findings include the following; loss of vascular pattern, Granular and fragile mucosa, friability, ulcerations, erosions, pseudo-polyposis.

Exclusion Criteria

• Patients with UC who are under age of 18 years old.
• Pregnancy.
• Previous colectomy.
• Patient refuse to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Visceral Adipose Tissue Volume Measured by MRI (Liters) from Baseline to Week 8	Baseline (pre-treatment) and after induction dose (typically 6-8 weeks post-initiation of biological therapy)	Change in visceral adipose tissue volume (in liters) measured using abdominal MRI before treatment and after the induction phase (6-8 weeks) of biological therapy in patients with ulcerative colitis
Effectiveness of Biological Therapy in UC Patients Based on Changes in Visceral Adipose Tissue (VAT) by MRI	Baseline (pre-treatment) and after induction dose (typically 6-8 weeks post-initiation of biological therapy)	Change in visceral fat volume and distribution as assessed by MRI before and after the induction phase of biological therapy in patients with ulcerative colitis. MRI scans will be analyzed to determine the relationship between VAT and treatment response, considering clinical and endoscopic outcomes.