Status:
RECRUITING
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
University of Padova
Catholic University of the Sacred Heart
Conditions:
Functional Gastrointestinal Disorders (FGIDs)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations i...
Eligibility Criteria
Inclusion Criteria:
- presence of clinically significant anxiety symptoms (DASS-21 > 4)
- presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS > 75);
- obtaining informed consent to participate in the study;
- Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);
- absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
Exclusion Criteria:
- absence of clinically significant anxiety symptoms (DASS-21< 4);
- absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS < 75);
- lack of obtaining Informed Consent to participate in the study;
- presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).
- presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06687057
Start Date
December 1 2024
End Date
January 31 2026
Last Update
August 24 2025
Active Locations (1)
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1
Eleonora Volpato
Milan, Italy, 20123