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

NCT05744258 | Completed Results

• 1 other identifier: BIA-IBS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Percentage of Total Body Water Between IBS Patients and Healthy Individuals

  percentage of total body water 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

Study Arms (2)

IBS patients

OTHER

Device: Bio-electrical impedance analysis

Healthy volunteers

OTHER

Device: Bio-electrical impedance analysis

Interventions

Bio-electrical impedance analysis DEVICE

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.

Healthy volunteers; IBS patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: prof. dr. Sebastien Kindt
• Organization: UZ Brussel

sebastien.kindt@uzbrussel.be

+32 2 477 60 11

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 24, 2023
• Study Start: August 22, 2022
• Primary Completion: May 22, 2024
• Study Completion: March 31, 2025
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)