N/A
N=40
The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05744258 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Comparison of the Phase Angle Between IBS Patients and Healthy Individuals — 5.78; 6.35 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bio-electrical impedance analysis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitair Ziekenhuis Brussel
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Phase Angle Between IBS Patients and Healthy Individuals |
5.78; 6.35 | — |
| PRIMARY Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals |
63.4; 72.3 | — |
| PRIMARY Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals |
42.9; 52.6 | — |
| PRIMARY Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals |
46.8; 53.7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05744258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.