Phase Angle and Chronic Intestinal Inflammatory Diseases

Phase Angle as a New Possible Prognostic Factor in Chronic Intestinal Inflammatory Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05106738

Acronym

PHIBO

Enrollment

100

Registered

2021-11-04

Start date

2021-06-01

Completion date

2023-11-30

Last updated

2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results