Phase Angle and Chronic Intestinal Inflammatory Diseases

Completed

• Conditions: C-Reactive Protein; Mucosal Inflammation; Inflammatory Bowel Diseases; Leukocyte L1 Antigen Complex

• Registration Number: NCT05106738
• Lead Sponsor: University of Bari

Brief Summary

Phase angle (PhA) is a biometric parameter measured by bioimpedance analysis (BIA), which reflects organism cellularity and tissues hydration. In addition, since it correlates with the presence of inflammation and the nutritional status, it could be useful to monitor inflammatory bowel disease (IBD) activity. The aim of this study was to establish the potential use of PhA as a new non-invasive and sensitive marker correlated with mucosal healing and/or IBD activity.

Detailed Description

Currently, fecal calprotectin is considered the best indirect marker inversely correlated with the mucosal healing in patients with inflammatory bowel disease (IBD). C reactive protein (CRP), is less reliable than fecal calprotectin in the evaluation of IBD activity. In order to establish the potential use of phase angle (PhA) as a new non-invasive and sensitive marker of mucosal healing and/or disease activity in patients with IBD, patients with diagnosis of chronic inflammatory bowel diseases (IBD) according to the European Crohn's and Colitis Organization (ECCO) guidelines will be enrolled. In these patients, the following parameters will be evaluated: age, sex, body mass index (BMI), percentage of weight loss in the last 6 months, duration of illness, location of disease, any previous intestinal surgery, ongoing therapy for IBD, activity disease by clinical scores, CRP, fecal calprotectin, disease activity by endoscopic scores, PhA and fat free mass (FFM).

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-10-23
• Study First Posted: 2021-11-04
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• histological report confirming the diagnosis of IBD,
• value of C-reactive protein (CRP)
• fecal calprotectin,
• colonoscopy within 3 months from the enrollment.

Exclusion Criteria

• presence of ascites or edema,
• chronic or autoimmune inflammatory diseases,
• ongoing infections,
• recent surgery (in the last 6 months),
• neoplastic diseases,
• ongoing enteral or parenteral nutrition,
• presence of fistulae,
• ileostomy or colostomy,
• short bowel syndrome,
• pregnancy or lactation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation of phase angle with mucosal healing in patients with inflammatory bowel disease	At enrollment	The evaluation of phase angle (PhA), expressed in degrees, will be obtained by bioimpedenziometry, using a specific software (Bodygram Pro 3.0, Akern srl, Pontassieve, Italy). The assessment of mucosal healing will be performed by the following endoscopic scores: the Simple Endoscopic Score for Crohn's Disease (SES-CD) and the Mayo endoscopic score for Crohn's disease and Ulcerative Colitis (UC), respectively.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the presence of malnutrition by bioimpedance analysis	At enrollment	Malnutrition will be assessed by the evaluation of body composition \[fat free mass (FFM) and fat mass (FM) expressed in kg\], by bioimpedance analysis

Trial Locations

Locations (1)

Michele Barone; 🇮🇹 Bari, BA, Italy