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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Page 1 of 1 (1 locations)

1

Eleonora Volpato

Milan, Italy, 20123

A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID) | DecenTrialz