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Completed

NCT Number: NCT05106738

Phase Angle and Chronic Intestinal Inflammatory Diseases

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michele Barone

Bari, BA, 70124, Italy

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Evaluation of the presence of malnutrition by bioimpedance analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: PHIBO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2021
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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