Recruiting NCT07196735
Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia, BIA, Fat Free Mass, Fat Mass. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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)]
- 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)]
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Belgium · 1 center
- UZ Brussel — Brussels
Identifiers
NCT: NCT07196735 · BIA in FD