Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS patients | Other |
| |
| Healthy volunteers | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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. | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Brussels Capital | 1090 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Signing of the ICF, screening and baseline visit were all done on the same day. One patient withdrew consent and was excluded.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IBS Patients | patients having irritable bowel disease |
| FG001 | Healthy Volunteers | participants not having irritable bowel disease or bowel problems |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IBS Patients | patients having irritable bowel disease |
| BG001 | Healthy Volunteers | patients not having irritable bowel disease or any bowel problems |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Standard Deviation | degrees | The phase angle will be assessed through study completion, an average 6 months |
|
from enrollment until end of follow up, up to 1 week
safety was checked for all patients, however every patient only performed 1 visit. They were followed until 1 week after that visit regarding safety but no AE's, SAE's or deaths occurred.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IBS Patients | participants suffering from IBS | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| prof. dr. Sebastien Kindt | UZ Brussel | +32 2 477 60 11 | sebastien.kindt@uzbrussel.be |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2021 | May 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Median | Standard Deviation | kg/m2 |
|
| Healthy Volunteers |
participants not suffering from irritable bowel syndrome |
|
|
| 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. | Posted | Median | Standard Deviation | % of total body water | The body composition will be assessed through study completion, an average 6 months |
|
|
|
| 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. | Posted | Median | Standard Deviation | % of muscle mass | the muscle mass will be assessed through study completion, an average 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | % of fat free mass | the percentage of body fat will be assessed through study completion, an average 6 months |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Healthy Volunteers | participants not suffering from IBS | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |