Bioelectrical impedance comparison of body composition in women with functional dyspepsia and healthy women

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

This project will use a quick, noninvasive bioelectrical impedance scan to see if women with functional dyspepsia have different fat mass, fat‑free mass, or phase angle compared with healthy women.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Brussels)
• Trial ID: NCT07196735 on ClinicalTrials.gov

What this trial studies

This observational study will compare bioelectrical impedance analysis (BIA) measurements—including phase angle, fat-free mass, and fat mass—between women who meet Rome IV criteria for functional dyspepsia and age-matched healthy women. All participants will undergo a noninvasive BIA measurement at UZ Brussel and clinical records including recent upper GI endoscopy will be reviewed to confirm eligibility. The protocol excludes participants with identified organic GI disease, untreated H. pylori, major systemic or psychiatric disorders, or certain prior abdominal surgeries to reduce confounding. Results will report group differences and may identify body composition features associated with functional dyspepsia symptoms.

Who should consider this trial

Good fit: Women aged 18 to 75 who meet Rome IV criteria for functional dyspepsia with an upper GI endoscopy in the past 12 months that excludes organic disease (mild gastritis allowed) are the intended participants, along with age-matched healthy women as controls.

Not a fit: Men and patients with known organic GI disease, untreated H. pylori infection, major systemic or autoimmune disorders affecting the GI tract, significant psychiatric illness, substance abuse, or recent major abdominal surgery are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If differences are found, the results could help identify body composition markers that inform nutritional counseling or targeted management for women with functional dyspepsia.

How similar studies have performed: BIA and phase angle have been used in other gastrointestinal and nutritional research with some reported associations to symptoms or outcomes, but application specifically to functional dyspepsia is limited.

Eligibility criteria

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.

Where this trial is running

Brussels

• UZ Brussel — Brussels, Belgium (Recruiting)

Study contacts

• Study coordinator: Sebastien Kindt

Conditions Functional Dyspepsia; BIA; Fat Free Mass; Fat Mass; Phase Angle