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

U

Universitair Ziekenhuis Brussel

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Device: Bio-electrical impedance analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT05744258
BIA-IBS

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

IBS patients
Other group
Treatment:
Device: Bio-electrical impedance analysis
Healthy volunteers
Other group
Treatment:
Device: Bio-electrical impedance analysis

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Sébastien Kindt

Data sourced from clinicaltrials.gov

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