An interventional study of Bio-electrical impedance analysis in Irritable Bowel Syndrome, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Other
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 40 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
Device: Bio-electrical impedance analysis
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°/π). Body composition, including muscle mass and percentage body fat will be calculated.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: the percentage of body fat will be assessed through study completion, an average 6 months
Our first patient was recruited on the 22nd of August 2022. The last patient entered the study on 15JUN2023. Patients with IBS were recruited at the gastro-enterology department. Healthy volunteers were asked to participate in the hospital.
| Milestone | IBS Patients | Healthy Volunteers |
|---|---|---|
| Started | 20 | 20 |
| Completed | 16 | 20 |
| Not completed | 4 | 0 |
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).
| degrees | IBS Patients | Healthy Volunteers |
|---|---|---|
| Comparison of the Phase Angle Between IBS Patients and Healthy Individuals | 5.78 ± 0.53 | 6.35 ± 0.65 |
percentage of total body water will be calculated using the measurements obtained during the BIA analysis.
| % of total body water | IBS Patients | Healthy Volunteers |
|---|---|---|
| Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals | 63.4 ± 9.8 | 72.3 ± 7.8 |
The muscle mass will be calculated using the measurements obtained during the BIA analysis.
| % of muscle mass | IBS Patients | Healthy Volunteers |
|---|---|---|
| Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals | 42.9 ± 6.39 | 52.6 ± 5.44 |
percentage of body fat will be calculated using the measurements obtained during the BIA analysis.
| % of fat free mass | IBS Patients | Healthy Volunteers |
|---|---|---|
| Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals | 46.8 ± 6.8 | 53.7 ± 3.8 |
Collected over from enrollment until end of follow up, up to 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IBS Patients | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Healthy Volunteers | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | IBS Patients | Healthy Volunteers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 19 | 35 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | IBS Patients | Healthy Volunteers | Total |
|---|---|---|---|
| Female | 14 | 9 | 23 |
| Male | 2 | 11 | 13 |
| Race and Ethnicity Not Collected(Participants) | IBS Patients | Healthy Volunteers | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m2) | IBS Patients | Healthy Volunteers | Total |
|---|---|---|---|
| Median | 27.23 ± 6.46 | 23.77 ± 3.76 | 25.54 ± 5.11 |
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Universitair Ziekenhuis Brussel