NCT06687057 A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
| NCT ID | NCT06687057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus |
| Condition | Functional Gastrointestinal Disorders (FGIDs) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-12-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students. The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06687057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Functional Gastrointestinal Disorders (FGIDs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06687057 currently recruiting?
Yes, NCT06687057 is actively recruiting participants. Contact the research team at eleonora.volpato@unicatt.it for enrollment information.
Where is the NCT06687057 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06687057 clinical trial?
NCT06687057 is sponsored by Fondazione Don Carlo Gnocchi Onlus. The trial plans to enroll 40 participants.