Heart-rate variability (HRV) biofeedback for gut–brain symptoms

A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.

This project tests whether HRV biofeedback can reduce stress and gut symptoms in college students who have functional gastrointestinal disorders and clinically significant anxiety.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT06687057 on ClinicalTrials.gov

What this trial studies

College students with functional gastrointestinal disorder symptoms and elevated anxiety will be identified through online screening and enrolled at the Milan site. Eligible participants (IBS-SSS > 75 and DASS-21 anxiety > 4, without organic GI, cardiovascular, or major neurological disease) will be assigned to receive HRV biofeedback training or a placebo training. The interventions aim to change autonomic balance, and outcomes will include changes in HRV metrics, stress/anxiety scores, and validated GI symptom scales. Data will be collected before and after the training to compare symptom and physiological changes between groups.

Who should consider this trial

Good fit: Ideal participants are college-aged adults with clinically significant anxiety (DASS-21 > 4) and notable FGID symptoms (IBS-SSS > 75) who have no organic gastrointestinal disease and no major cardiac or neurological conditions.

Not a fit: People with diagnosed organic GI diseases, significant cardiovascular or neurological disorders, or without clinically significant anxiety or FGID symptom scores are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could provide a non-drug way to lower stress and reduce functional GI symptoms by improving autonomic regulation.

How similar studies have performed: Prior small studies and pilot work indicate HRV biofeedback can improve parasympathetic tone and reduce stress, with some promising but not yet definitive results for symptom relief in FGIDs.

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.).

Where this trial is running

Milan

• Eleonora Volpato — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: Eleonora Volpato, PsyD, PhD

Conditions Functional Gastrointestinal Disorders