Functional Gastrointestinal Disorders (FGIDs)BF_FDGINCT06687057
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
A study testing HRV Biofeedback Training in people with Functional Gastrointestinal Disorders (FGIDs), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGIDs)
- What is being tested?
- HRV Biofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elisabetta Patron, PsyD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Eleonora Volpato
Milan, 20123
Eleonora Volpato, PsyD, PhD, eleonora.volpato@unicatt.it
About this study
Official title: A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.
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.
- Being tested
- HRV Biofeedback Training, Placebo Training
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV Biofeedback TrainingBehavioural
The intervention involves 5 training sessions lasting 45 minutes (specifically, 5-minute baseline and 5 HRV biofeedback trials lasting 5 minutes each) according to the protocol published by Lehrer et al. (2013). Physiological signals (ECG and respiratory rate) will be recorded during all sessions. During the training, participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing. They will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle in order to maximize the difference between the maximum and minimum heart rate within each respiratory cycle [i.e., respiratory sinus arrhythmia (RSA), an index of vagal modulation on the heart] (Lehrer et al., 2003; Lehrer et al., 2000).
Placebo TrainingOther
The Placebo procedure requires participants to attend 5 sessions lasting 45 minutes during which they perform a task. Physiological signals (ECG and respiration rate) will be recorded during all sessions. Participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing but these will not directly reflect the subject's cardiorespiratory activity. Participants in the control group will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle, but the feedback on the screen will not reflect that subject's RSA changes.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | The actual administration of the HRV-Biofeedback protocol: 5 HRV biofeedback training sessions of 45 minutes each, conducted biweekly. Receives: Behavioral: HRV Biofeedback Training |
| Placebo | Placebo comparator | Placebo condition: 5 control sessions of 45 minutes each, conducted biweekly. Receives: Other: Placebo Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Stress
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Emotion Regulation
The Emotion Regulation Questionnaire (ERQ) is composed of ten items divided into two factors: cognitive reappraisal with six items and expressive suppression with four items. It is answered on a Likert scale ranging from 1 (total disagreement) to 7 (total agreement).
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Irritable Bowel Severity
This scale evaluates primarily the intensity of IBS symptoms during a 10-day period: abdominal pain, distension, stool frequency and consist- ency, and interference with life in general. The IBS-SSS calculates the sum of these 5 items each scored on a visual analog scale from 0 to 100. Although the IBS-SSS uses patient-rated intensity of IBS symptoms, the determination of severity by the scoring system was originally anchored to a physician's assessment of patient severity.
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Heart Rate Variability
Electrocardiogram (ECG) and Heart Rate Variability in particular, recorded through three Ag/AgCl electrodes placed with a proximal type fitting, using the second Einthoven lead. Heart rate and HRV parameters in time and frequency and nonlinear indices will be extracted from the ECG. They will also be monitored during the proposed training (experimental and control).
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Secondary outcomes (4)
Interception
The Body Perception Questionnaire (BPQ) is a self-report measure of body awareness and autonomic symptoms (i.e. symptoms experienced in organs innervated by the ANS). Its items are based on the organization of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and body.
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Emotional State
The PANAS is a self-report measure used to assess levels of positive and negative affect. It consists of 20 items asking the extent to which the respondent has experienced different emotions during a given timeframe.
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Respiratory Rate
Respiratory rate (RR) recorded through bands (strain gauges) placed around the chest and around the abdomen. It will be monitored during both the experimental and control treatments
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Depression
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Measured: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Dec 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal Disorders (FGIDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687057
- Sponsor's protocol ID
- UCSC_123_24
- Acronym
- BF_FDGI
- Status last verified
- Aug 2025
- First submitted
- 10 Nov 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lehrer PM, Vaschillo E, Vaschillo B, Lu SE, Eckberg DL, Edelberg R, Shih WJ, Lin Y, Kuusela TA, Tahvanainen KU, Hamer RM. Heart rate variability biofeedback increases baroreflex gain and peak expiratory flow. Psychosom Med. 2003 Sep-Oct;65(5):796-805. doi: 10.1097/01.psy.0000089200.81962.19.
PubMed 14508023Mather M, Thayer J. How heart rate variability affects emotion regulation brain networks. Curr Opin Behav Sci. 2018 Feb;19:98-104. doi: 10.1016/j.cobeha.2017.12.017.
PubMed 29333483Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
PubMed 28478782
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.
- ClinicalTrials.gov ID
- NCT06687057
- Acronym / sponsor ID
- BF_FDGI / UCSC_123_24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Padova, Catholic University of the Sacred Heart
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: HRV Biofeedback TrainingThe actual administration of the HRV-Biofeedback protocol: 5 HRV biofeedback training sessions of 45 minutes each, conducted biweekly. |
| Placebo | Placebo comparator | Other: Placebo TrainingPlacebo condition: 5 control sessions of 45 minutes each, conducted biweekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV Biofeedback TrainingThe intervention involves 5 training sessions lasting 45 minutes (specifically, 5-minute baseline and 5 HRV biofeedback trials lasting 5 minutes each) according to the protocol published by Lehrer et al. (2013). Physiological signals (ECG and respiratory rate) will be recorded during all sessions. During the training, participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing. They will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle in order to maximize the difference between the maximum and minimum heart rate within each respiratory cycle [i.e., respiratory sinus arrhythmia (RSA), an index of vagal modulation on the heart] (Lehrer et al., 2003; Lehrer et al., 2000). | Behavioural | Biofeedback |
| Placebo TrainingThe Placebo procedure requires participants to attend 5 sessions lasting 45 minutes during which they perform a task. Physiological signals (ECG and respiration rate) will be recorded during all sessions. Participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing but these will not directly reflect the subject's cardiorespiratory activity. Participants in the control group will be asked to synchronize the two signals so that the changes in heart rate are in phase with the respiratory cycle, but the feedback on the screen will not reflect that subject's RSA changes. | Other | Placebo |
Primary outcome
Anxiety
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Stress
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Depression Anxiety Stress Scales - 21 (DASS-21) is 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults older adolescents (17 years +).
Emotion Regulation
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
The Emotion Regulation Questionnaire (ERQ) is composed of ten items divided into two factors: cognitive reappraisal with six items and expressive suppression with four items. It is answered on a Likert scale ranging from 1 (total disagreement) to 7 (total agreement).
Irritable Bowel Severity
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
This scale evaluates primarily the intensity of IBS symptoms during a 10-day period: abdominal pain, distension, stool frequency and consist- ency, and interference with life in general. The IBS-SSS calculates the sum of these 5 items each scored on a visual analog scale from 0 to 100. Although the IBS-SSS uses patient-rated intensity of IBS symptoms, the determination of severity by the scoring system was originally anchored to a physician's assessment of patient severity.
Heart Rate Variability
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Electrocardiogram (ECG) and Heart Rate Variability in particular, recorded through three Ag/AgCl electrodes placed with a proximal type fitting, using the second Einthoven lead. Heart rate and HRV parameters in time and frequency and nonlinear indices will be extracted from the ECG. They will also be monitored during the proposed training (experimental and control).
4 secondary outcomes
Interception
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Emotional State
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Respiratory Rate
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Depression
Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 14508023Lehrer PM, Vaschillo E, Vaschillo B, Lu SE, Eckberg DL, Edelberg R, Shih WJ, Lin Y, Kuusela TA, Tahvanainen KU, Hamer RM. Heart rate variability biofeedback increases baroreflex gain and peak expiratory flow. Psychosom Med. 2003 Sep-Oct;65(5):796-805. doi: 10.1097/01.psy.0000089200.81962.19.
- Results publication: PubMed 29333483Mather M, Thayer J. How heart rate variability affects emotion regulation brain networks. Curr Opin Behav Sci. 2018 Feb;19:98-104. doi: 10.1016/j.cobeha.2017.12.017.
- Results publication: PubMed 28478782Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabetta Patron, PsyD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV Biofeedback Training in people with Functional Gastrointestinal Disorders (FGIDs), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Volpato, PsyD, PhD (3293782692 ext. 0039, eleonora.volpato@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06687057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.