Phase Angle and Chronic Intestinal Inflammatory Diseases

NCT05106738 | Completed

• 1 other identifier: Policlinic hospital, 9
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The correlation of phase angle with mucosal healing in patients with inflammatory bowel disease

  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.

  At enrollment

Secondary Outcomes (1)

• Evaluation of the presence of malnutrition by bioimpedance analysis

  At enrollment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease and patients with Ulcerative Colitis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Michele Barone

Bari, BA, 70124, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Michele Barone, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 4, 2021
• Study Start: June 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

IT (1)