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Completed

NCT Number: NCT05744258

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Comparison of the Phase Angle Between IBS Patients and Healthy Individuals

    Time frame: 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).

  2. Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals

    Time frame: The body composition will be assessed through study completion, an average 6 months

    percentage of total body water will be calculated using the measurements obtained during the BIA analysis.

  3. Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals

    Time frame: 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.

  4. Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: BIA-IBS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
May 29, 2025

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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