The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: Bio-electrical impedance analysis

• Registration Number: NCT05744258
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

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 Timeline

• Study Start: 2022-08-22
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Bio-electrical impedance analysis	-
IBS patients	Bio-electrical impedance analysis	-

Primary Outcome Measures

Name	Time	Method
comparison of the body composition between IBS patients and healthy individuals	The body composition will be assessed through study completion, an average 6 months	Body composition will be calculated using the measurements obtained during the BIA analysis.
comparison of the percentage of body fat between IBS patients and healthy individuals	the percentage of body fat will be assessed through study completion, an average 6 months	percentage of body fat will be calculated using the measurements obtained during the BIA analysis.
comparison of the phase angle between IBS patients and healthy individuals	The phase angle will be assessed through study completion, an average 6 months	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).
comparison of the muscle mass between IBS patients and healthy individuals	the muscle mass will be assessed through study completion, an average 6 months	The muscle mass will be calculated using the measurements obtained during the BIA analysis.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Brussels, Belgium