Image

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

Recruiting
18 - 75 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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

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.

Study details

Irritable Bowel Syndrome

NCT05744258

Universitair Ziekenhuis Brussel

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.