Irritable Bowel Syndrome
Conditions
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.
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.
Interventions
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.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Phase Angle Between IBS Patients and Healthy Individuals | 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 | 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 | 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 | 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. |
Countries
Belgium
Participant flow
Recruitment details
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.
Pre-assignment details
Signing of the ICF, screening and baseline visit were all done on the same day. One patient withdrew consent and was excluded.
Participants by arm
| Arm | Count |
|---|---|
| IBS Patients patients having irritable bowel disease | 16 |
| Healthy Volunteers patients not having irritable bowel disease or any bowel problems | 20 |
| Total | 36 |
Baseline characteristics
| Characteristic | IBS Patients | Healthy Volunteers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 19 Participants | 35 Participants |
| BMI | 27.23 kg/m2 STANDARD_DEVIATION 6.46 | 23.77 kg/m2 STANDARD_DEVIATION 3.76 | 25.54 kg/m2 STANDARD_DEVIATION 5.11 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| IBS Patients | Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals | 42.9 % of muscle mass | Standard Deviation 6.39 |
| Healthy Volunteers | Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals | 52.6 % of muscle mass | Standard Deviation 5.44 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IBS Patients | Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals | 46.8 % of fat free mass | Standard Deviation 6.8 |
| Healthy Volunteers | Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals | 53.7 % of fat free mass | Standard Deviation 3.8 |
Primary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| IBS Patients | Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals | 63.4 % of total body water | Standard Deviation 9.8 |
| Healthy Volunteers | Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals | 72.3 % of total body water | Standard Deviation 7.8 |
Primary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| IBS Patients | Comparison of the Phase Angle Between IBS Patients and Healthy Individuals | 5.78 degrees | Standard Deviation 0.53 |
| Healthy Volunteers | Comparison of the Phase Angle Between IBS Patients and Healthy Individuals | 6.35 degrees | Standard Deviation 0.65 |