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

Irritable Bowel Syndrome Clinical Trial

— BIA-IBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744258
• Other study ID #: BIA-IBS
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: February 15, 2026

Study information

• Verified date: January 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Sébastien Kindt
• Phone: +32 2 477
• Email: sebastien.kindt[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 15, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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°/p). Body composition, including muscle mass and percentage body fat will be calculated.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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°/p).	The phase angle will be assessed through study completion, an average 6 months
Primary	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
Primary	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
Primary	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