Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorUniversitair Ziekenhuis Brussel
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial population
female patients with or without FD between 18 and 75 years
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: patients with FD
Group B: healthy patients
Trial outcomes
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)Sponsors and contacts
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Source ClinicalTrials.gov