Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

NCT07196735 | Recruiting

• 1 other identifier: BIA in FD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Difference in phase angle between healthy patients and patients with FD

  from signing of the ICF till end of study (on average 1 week)

• Difference in fat mass between healthy patients and patients with FD

  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

  from signing of the ICF till end of study (on average 1 week)

Study Arms (2)

patients with FD

healthy patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female patients with or without FD between 18 and 75 years

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Central Study Contacts

Sebastien Kindt

CONTACT

+3224776011; sebastien.kindt@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)