Clinical trial NCT05744258: The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Official title: A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Comparison of the Phase Angle Between IBS Patients and Healthy Individuals
timeFrame: The phase angle will be assessed through study completion, an average 6 months
measure: Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals
timeFrame: The body composition will be assessed through study completion, an average 6 months
measure: Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals
timeFrame: the muscle mass will be assessed through study completion, an average 6 months
measure: Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals
timeFrame: the percentage of body fat will be assessed through study completion, an average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References: