Inflammatory Bowel Diseases Clinical Trial
— PHIBOOfficial title:
Phase Angle as a New Possible Prognostic Factor in Chronic Intestinal Inflammatory Diseases
Verified date | December 2023 |
Source | University of Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 30, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Michele Barone | Bari | BA |
Lead Sponsor | Collaborator |
---|---|
University of Bari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evaluation of the presence of malnutrition by bioimpedance analysis | Malnutrition will be assessed by the evaluation of body composition [fat free mass (FFM) and fat mass (FM) expressed in kg], by bioimpedance analysis | At enrollment |
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