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NCT Number: NCT07196735

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

The primary objective of this study is to compare the BIA parameters, including Phase Angle, Fat Free Mass and Fat Mass, between women with functional dyspepsia and healthy women. All woman will undergo a bio-electrical impedance monitoring for this.

Recruiting

Interested in participating?

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 - 75 years
  • Fulfilling the ROME IV criteria for functional dyspepsia (for FD patients)
  • FD unexplained by upper GI endoscopy during the past 12 months (mild gastritis allowed) (for FD patients).

Exclusion criteria

  • Clinical suspicion of an organic disorder different from FD (patients can be included when this disorder had been excluded);
  • Abnormality on upper GI endoscopy other than mild gastritis (for FD patients).
  • Known reflux oesophagitis Los Angeles grade C or D, known Barrett oesophagus, peptic stricture.
  • H pylori infection, unless treated at least 6 months before;
  • 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);
  • Treatment with PPI's during the past 8 weeks
  • Pregnancy.

Treatment and study plan

Primary outcomes

  1. Difference in phase angle between healthy patients and patients with FD

    Time frame: from signing of the ICF till end of study (on average 1 week)

  2. Difference in fat mass between healthy patients and patients with FD

    Time frame: from signing of the ICF till end of study (on average 1 week)

  3. Difference in fat free mass between healthy patients and patients with FD

    Time frame: from signing of the ICF till end of study (on average 1 week)

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastien Kindt

CONTACT

[email protected]

+3224776011

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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