Trial Outcomes & Findings for The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome (NCT NCT05744258)
NCT ID: NCT05744258
Last Updated: 2025-05-29
Results Overview
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).
COMPLETED
NA
40 participants
The phase angle will be assessed through study completion, an average 6 months
2025-05-29
Participant Flow
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.
Signing of the ICF, screening and baseline visit were all done on the same day. One patient withdrew consent and was excluded.
Participant milestones
| Measure |
IBS Patients
patients having irritable bowel disease
|
Healthy Volunteers
participants not having irritable bowel disease or bowel problems
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IBS Patients
n=16 Participants
patients having irritable bowel disease
|
Healthy Volunteers
n=20 Participants
patients not having irritable bowel disease or any bowel problems
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
19 Participants
n=20 Participants
|
35 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=16 Participants
|
9 Participants
n=20 Participants
|
23 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=16 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
27.23 kg/m2
STANDARD_DEVIATION 6.46 • n=16 Participants
|
23.77 kg/m2
STANDARD_DEVIATION 3.76 • n=20 Participants
|
25.54 kg/m2
STANDARD_DEVIATION 5.11 • n=36 Participants
|
PRIMARY outcome
Timeframe: The phase angle will be assessed through study completion, an average 6 monthsBio-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).
Outcome measures
| Measure |
IBS Patients
n=16 Participants
patients suffering from irritable bowel syndrome
|
Healthy Volunteers
n=20 Participants
participants not suffering from irritable bowel syndrome
|
|---|---|---|
|
Comparison of the Phase Angle Between IBS Patients and Healthy Individuals
|
5.78 degrees
Standard Deviation 0.53
|
6.35 degrees
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: The body composition will be assessed through study completion, an average 6 monthspercentage of total body water will be calculated using the measurements obtained during the BIA analysis.
Outcome measures
| Measure |
IBS Patients
n=16 Participants
patients suffering from irritable bowel syndrome
|
Healthy Volunteers
n=20 Participants
participants not suffering from irritable bowel syndrome
|
|---|---|---|
|
Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals
|
63.4 % of total body water
Standard Deviation 9.8
|
72.3 % of total body water
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: the muscle mass will be assessed through study completion, an average 6 monthsThe muscle mass will be calculated using the measurements obtained during the BIA analysis.
Outcome measures
| Measure |
IBS Patients
n=16 Participants
patients suffering from irritable bowel syndrome
|
Healthy Volunteers
n=20 Participants
participants not suffering from irritable bowel syndrome
|
|---|---|---|
|
Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals
|
42.9 % of muscle mass
Standard Deviation 6.39
|
52.6 % of muscle mass
Standard Deviation 5.44
|
PRIMARY outcome
Timeframe: the percentage of body fat will be assessed through study completion, an average 6 monthspercentage of body fat will be calculated using the measurements obtained during the BIA analysis.
Outcome measures
| Measure |
IBS Patients
n=16 Participants
patients suffering from irritable bowel syndrome
|
Healthy Volunteers
n=20 Participants
participants not suffering from irritable bowel syndrome
|
|---|---|---|
|
Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals
|
46.8 % of fat free mass
Standard Deviation 6.8
|
53.7 % of fat free mass
Standard Deviation 3.8
|
Adverse Events
IBS Patients
Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place