Functional DyspepsiaNCT07196735
Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
An observational study of Functional Dyspepsia and BIA, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, BIA, Fat Free Mass
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female patients with or without FD between 18 and 75 years
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
Sebastien Kindt, +3224776011, sebastien.kindt@uzbrussel.be
About this study
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.
- Conditions
- Functional Dyspepsia, BIA, Fat Free Mass, Fat Mass, Phase Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with FD | Not described | |
| healthy patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in phase angle between healthy patients and patients with FD
Measured: from signing of the ICF till end of study (on average 1 week)
Difference in fat mass between healthy patients and patients with FD
Measured: 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
Measured: from signing of the ICF till end of study (on average 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start18 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196735
- Sponsor's protocol ID
- BIA in FD
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07196735
- Acronym / sponsor ID
- BIA in FD
- Conditions
- Functional Dyspepsia, BIA, Fat Free Mass, Fat Mass, Phase Angle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with FD | – | – |
| healthy patients | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with or without FD between 18 and 75 years
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and BIA, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien Kindt (+3224776011, sebastien.kindt@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.