Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07196735

Enrollment

Registered

2025-09-29

Start date

2025-09-18

Completion date

2026-12-31

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BIA, Fat Free Mass, Fat Mass, Functional Dyspepsia, Phase Angle

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Difference in phase angle between healthy patients and patients with FD	from signing of the ICF till end of study (on average 1 week)
Difference in fat mass between healthy patients and patients with FD	from signing of the ICF till end of study (on average 1 week)
Difference in fat free mass between healthy patients and patients with FD	from signing of the ICF till end of study (on average 1 week)

Countries

Belgium

Contacts

Primary ContactSebastien Kindt

sebastien.kindt@uzbrussel.be+3224776011

Outcome results