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NCT06687057: BF_FDGI
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
NA trial testing HRV Biofeedback Training in Functional Gastrointestinal Disorders (FGIDs) in 40 participants. Currently enrolling.
30 November 2025
Quick facts
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 December 2024 |
| Primary completion | 30 November 2025 |
| Estimated completion | 31 January 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- HRV Biofeedback Training
- Placebo Training
Conditions studied
- Functional Gastrointestinal Disorders (FGIDs) — all drugs for Functional Gastrointestinal Disorders (FGIDs) →
Sponsor
Fondazione Don Carlo Gnocchi Onlus — full company profile →
Who can join
18 and older, any sex, with Functional Gastrointestinal Disorders (FGIDs). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06687057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Functional Gastrointestinal Disorders (FGIDs)
Currently open trials in the same condition.
- NCT07000227 — Mechanism of FODMAP Restriction on FGID Patients · NA · recruiting
Other Fondazione Don Carlo Gnocchi Onlus trials
Trials by the same sponsor.
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- NCT07290218 — Tridimensional Robotic Assessment of Neglect in Brain Injured Patients · not yet recruiting
- NCT07064226 — Validation of a Digital Intervention to Rehabilitate Cognitive Resources · NA · recruiting
- NCT07130929 — Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study. · NA · recruiting
- NCT07159854 — Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06687057 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus
- Last refreshed: 24 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06687057.
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