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Phase Angle and Chronic Intestinal Inflammatory Diseases

NCT ID: NCT05106738

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-11-30

Brief Summary

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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

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bari

OTHER

Sponsor Role lead

Responsible Party

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Michele Barone

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Barone, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

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Michele Barone

Bari, BA, Italy

Site Status

Countries

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Italy

Other Identifiers

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Policlinic hospital, 9

Identifier Type: -

Identifier Source: org_study_id