Irritable Bowel SyndromeBIA-IBSNCT05744258

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

A study testing Bio-electrical impedance analysis in people with Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: Bio-electrical impedance analysis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBelgium
Study dates: 22 Aug 2022to 31 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Brussel
Brussels, Brussels Capital, 1090

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions: Irritable Bowel Syndrome
Being tested: Bio-electrical impedance analysis
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bio-electrical impedance analysisDevice
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.

Study groups in NCT05744258
Study group	Role	What they receive
IBS patients	Other	Not described Receives: Device: Bio-electrical impedance analysis
Healthy volunteers	Other	Not described Receives: Device: Bio-electrical impedance analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the percentage of body fat will be assessed through study completion, an average 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202231 Mar 2025

First posted24 Feb 2023
Study start22 Aug 2022
Primary completion22 May 2024
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05744258
Sponsor's protocol ID: BIA-IBS
Acronym: BIA-IBS
Status last verified: Mar 2025
First submitted: 27 Jan 2023
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT05744258
Acronym / sponsor ID: BIA-IBS / BIA-IBS
Conditions: Irritable Bowel Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Universitair Ziekenhuis BrusselUniversity, hospital or other
Study start: 22 Aug 2022 (actual)
Primary completion: 22 May 2024 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 24 Feb 2023 (actual)
Results: Posted 29 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IBS patients	Other	Device: Bio-electrical impedance analysis
Healthy volunteers	Other	Device: Bio-electrical impedance analysis

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bio-electrical impedance analysisBio-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.	Device	Healthy volunteers, IBS patients

Primary outcome

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).
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.
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.
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.

Results and safety

Results posted to the registry on 29 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IBS Patients	20	16
Healthy Volunteers	20	20

Primary outcome: 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. Median (Standard Deviation). Unit: degrees

Measure	IBS Patients n = 16	Healthy Volunteers n = 20
Value	5.78 (0.53)	6.35 (0.65)

Primary outcome: 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. Median (Standard Deviation). Unit: % of total body water

Measure	IBS Patients n = 16	Healthy Volunteers n = 20
Value	63.4 (9.8)	72.3 (7.8)

Primary outcome: 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. Median (Standard Deviation). Unit: % of muscle mass

Measure	IBS Patients n = 16	Healthy Volunteers n = 20
Value	42.9 (6.39)	52.6 (5.44)

Primary outcome: 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. Mean (Standard Deviation). Unit: % of fat free mass

Measure	IBS Patients n = 16	Healthy Volunteers n = 20
Value	46.8 (6.8)	53.7 (3.8)

Adverse events

Time frame: from enrollment until end of follow up, up to 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IBS Patients	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Healthy Volunteers	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Irritable Bowel Syndrome

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bio-electrical impedance analysis in people with Irritable Bowel Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.