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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Brussel
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Sebastien Kindt
• Email: sebastien.kindt@uzbrussel.be
• Phone: +3224776011

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.