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The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome (BIA-IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bio-electrical impedance analysis
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

IBS patients

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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).
comparison of the body composition between IBS patients and healthy individuals
Body composition 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 calculated using the measurements obtained during the BIA analysis.
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
February 15, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05744258
Brief Title
The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Acronym
BIA-IBS
Official Title
A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBS patients
Arm Type
Other
Arm Title
Healthy volunteers
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Bio-electrical impedance analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
comparison of the phase angle between IBS patients and healthy individuals
Description
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
Title
comparison of the body composition between IBS patients and healthy individuals
Description
Body composition 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
Title
comparison of the muscle mass between IBS patients and healthy individuals
Description
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
Title
comparison of the percentage of body fat between IBS patients and healthy individuals
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Kindt
Phone
+32 2 477
Ext
60 11
Email
sebastien.kindt@uzbrussel.be
Facility Information:
Facility Name
UZ Brussel
City
Brussel
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Kindt
Phone
+32 2 477
Ext
60 11
Email
sebastien.kindt@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome

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