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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Bio-electrical impedance analysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBS patients<br> | Device: Bio-electrical impedance analysis<br>* 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.<br>|
| Other: Healthy volunteers<br> | Device: Bio-electrical impedance analysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 |