The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome (BIA-IBS)

A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome

The study aim is to investigate the Bio-electrical Impedance (BIA) parameters in general, and phase angle (PhA) in particular in Irritable bowel syndrome (IBS) patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Device: Bio-electrical impedance analysis

Detailed Description

The role and significance of bio-electrical impedance analysis (BIA) has not been studied in IBS. Therefore, The investigators designed this exploratory study to assess its potential role in the diagnosis and follow-up of treatment in IBS. The study aim is to investigate the BIA parameters in general, and PhA in particular in IBS patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.

The primary objective is to compare the BIA parameters including PhA between IBS and healthy individuals.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien Kindt; Phone Number: 60 11 +32 2 477; Email: Sebastien.kindt@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Brussel, Brussels, Belgium, 1090
      • Recruiting
      • UZ Brussel
      • Contact: Sébastien Kindt; Phone Number: 60 11 +32 2 477; Email: Sebastien.kindt@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18 - 75 years;
• Fulfilling the ROME IV criteria for IBS (only for patients);

Exclusion Criteria:

• Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
• Known inflammatory bowel disorder;
• Known major intestinal motility disorder;
• Alcohol (defined as more than 14 U per week) or other substance abuse;
• Active psychiatric disorder;
• Known systemic or auto-immune disorder with implication for the GI system;
• Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);
• Any prior diagnosis of cancer other than basocellular carcinoma;
• Current chemotherapy;
• History of gastro-enteritis in the past 12 weeks;
• Dietary supplements unless taken at a stable dose for more than 12 weeks;
• Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers	Device: Bio-electrical impedance analysis; Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed. Reactance and resistance will be obtained. Phase angle will be calculated according to the formula: PhA (°) = (reactance/ resistance° x (180°/π). Body composition, including muscle mass and percentage body fat will be calculated.
Other: IBS patients	Device: Bio-electrical impedance analysis; Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed. Reactance and resistance will be obtained. Phase angle will be calculated according to the formula: PhA (°) = (reactance/ resistance° x (180°/π). Body composition, including muscle mass and percentage body fat will be calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of the phase angle between IBS patients and healthy individuals	Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed. Reactance and resistance will be obtained. Phase angle will be calculated according to the formula: PhA (°) = (reactance/ resistance° x (180°/π).	The phase angle will be assessed through study completion, an average 6 months
comparison of the body composition between IBS patients and healthy individuals	Body composition will be calculated using the measurements obtained during the BIA analysis.	The body composition will be assessed through study completion, an average 6 months
comparison of the muscle mass between IBS patients and healthy individuals	The muscle mass will be calculated using the measurements obtained during the BIA analysis.	the muscle mass will be assessed through study completion, an average 6 months
comparison of the percentage of body fat between IBS patients and healthy individuals	percentage of body fat will be calculated using the measurements obtained during the BIA analysis.	the percentage of body fat will be assessed through study completion, an average 6 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Anticipated): February 15, 2026
• Study Completion (Anticipated): February 15, 2026

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: BIA-IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No