Irritable Bowel SyndromeNCT06205446
Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction
A study testing Healthy subjects : abdominal breathing, Laryngopharyngeal reflux disease subjects : abdominal breathing and Dyspepsia subjects : abdominal breathing in people with Irritable Bowel Syndrome and Healthy Subjects, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Patients with disorders of gut-brain interaction (DGBI) often present gastrointestinal symptoms that do not show noticeable irregularities in standard examinations. However, due to unclear causes and a high prevalence rate, this condition often exerts a profound impact on the physical and mental health of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Healthy Subjects, Functional Gastrointestinal Disorders
- What is being tested?
- Healthy subjects : abdominal breathing, Laryngopharyngeal reflux disease subjects : abdominal breathing and Dyspepsia subjects : abdominal breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- No gastrointestinal symptoms or use of gastrointestinal medication.
- Inclusion criteria for Laryngopharyngeal reflux disease subjects:
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- Gastroesophageal reflux disease (GERD) is defined as the condition characterized by experiencing symptoms for at least three months (such as hoarseness, sensation of a foreign body in the throat, chronic cough, and frequent throat clearing) occurring at least once a week. Reflux Symptom Index (RSI) is a standardized questionnaire for evaluating laryngopharyngeal reflux. It consists of nine reflux-related symptoms, with severity scores ranging from 0 (no symptoms) to 5 (most severe). A total score exceeding 13 indicates the criteria for inclusion of a patient as having laryngopharyngeal reflux.
- dyspepsia subjects:
Show all 11Show fewer
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia is chronic ( once a week , lasting for at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following ) : postprandial abdominal distension, easy feeling of fullness, upper abdominal pain Or upper abdominal burning sensation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
- Inclusion criteria for subjects with irritable bowel disorder:
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- meet the definition of irritable bowel disorder (IBS) . Irritable bowel syndrome is chronic ( once a week , lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation , and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) .
Who cannot join
- Pregnant or lactating women.
- Infected with antibiotic resistance.
- Received endotracheal intubation in the past two months .
- Having myocardial ischemia or recently experienced a myocardial infarction.
- Unable to collaborate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Autonomic Nervous System
Patients with disorders of gut-brain interaction (DGBI) often present gastrointestinal symptoms that do not show noticeable irregularities in standard examinations. However, due to unclear causes and a high prevalence rate, this condition often exerts a profound impact on the physical and mental health of patients. The scope of DGBI encompasses conditions such as laryngopharyngeal reflux, functional dyspepsia, and irritable bowel syndrome. Previous research has confirmed that in patients with DGBI, their autonomic nervous system exhibits an imbalance, charact erized by decreased parasympathetic activity and dominant sympathetic activity. Diaphragmatic breathing helps reduce the respiratory rate and can stimulate parasympathetic activity while suppressing sympathetic activity. Hence, it is now officially recommended as an effective adjunct therapy for relieving symptoms of gastroesophageal reflux. Accordingly, this study plans to implement a randomized controlled trial, introducing diaphragmatic breathing to patients with DGBI who exhibit normal results in objective examinations. This work allows evaluate changes in their psychophysical symptoms before and after treatment, as well as alterations in the autonomic nervous system .
- Conditions
- Irritable Bowel Syndrome, Healthy Subjects, Functional Gastrointestinal Disorders, Laryngopharyngeal Reflux
- Being tested
- Healthy subjects : abdominal breathing, Laryngopharyngeal reflux disease subjects : abdominal breathing, Dyspepsia subjects : abdominal breathing, Irritable bowel disorder : abdominal breathing
- Keywords
- Heart rate variability, Diaphragmatic breathing, Gut-brain axis dysregulation
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy subjects : abdominal breathingBehavioural
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
Laryngopharyngeal reflux disease subjects : abdominal breathingBehavioural
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
Dyspepsia subjects : abdominal breathingBehavioural
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
Irritable bowel disorder : abdominal breathingBehavioural
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
| Study group | Role | What they receive |
|---|---|---|
| abdominal breathing | Experimental | The relationship between respiration and the autonomic nervous system (ANS) is closely intertwined, as the phrenic nerve, responsible for controlling the movement of the diaphragm, is connected to the vagus nerve of the parasympathetic nervous system.The respiratory cycle reflects the balance between the parasympathetic and sympathetic nervous systems in the Autonomic Nervous System (ANS), which can be observed through Heart Rate Variability (HRV). The ANS state shifts from the parasympathetic nervous system to the sympathetic nervous system during inhalation, while it transitions from the sympathetic nervous system to the parasympathetic nervous system during exhalation. In HRV, an increase in heart rate indicates enhanced sympathetic nervous system activity during inhalation, whereas a decrease in heart rate signifies increased parasympathetic nervous system activity during exhalation. Receives: Behavioral: Healthy subjects : abdominal breathing; Behavioral: Laryngopharyngeal reflux disease subjects : abdominal breathing; Behavioral: Dyspepsia subjects : abdominal breathing; Behavioral: Irritable bowel disorder : abdominal breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days
Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days
Possible scores range from 1 (Never) to 5 (Always)
1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days
Possible scores range from 1 (Never) to 3 (4~7days) 0=Never 1=1 day 2=2~3days 3=4~7days Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Reflux Symptom Index (RSI) at 14 days
Possible scores range from 0 (no symptoms) to 5 (most severe) 0= No Problem 1=very slight 2=slight 3=About medium 4=moderate to severe 5=Severe Problem Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days
Possible scores range from 1 (No pain) to 4 (Worst possible pain)
1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days
Possible scores range from 1 (Never) to 4 (Always)
1=Never 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days
Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days
Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days
Possible scores range from 1 (Strongly disagree) to 6 (Strongly agree)
1=Strongly agree 2=Moderately agree 3=Mildly agree 4=Mildly disagree 5 =Moderately disagree 6=Strongly disagree Change = (day 14 Score - Baseline Score).
Measured: Baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205446
- Sponsor's protocol ID
- IRB112-185-A
- Status last verified
- Aug 2023
- First submitted
- 28 Dec 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margolis KG, Cryan JF, Mayer EA. The Microbiota-Gut-Brain Axis: From Motility to Mood. Gastroenterology. 2021 Apr;160(5):1486-1501. doi: 10.1053/j.gastro.2020.10.066. Epub 2021 Jan 22.
PubMed 33493503Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
PubMed 27147121Wong MW, Hsiao SH, Wang JH, Yi CH, Liu TT, Lei WY, Hung JS, Liang SW, Lin L, Gyawali CP, Chen PR, Chen CL. Esophageal Hypervigilance and Visceral Anxiety Contribute to Symptom Severity of Laryngopharyngeal Reflux. Am J Gastroenterol. 2023 May 1;118(5):786-793. doi: 10.14309/ajg.0000000000002151. Epub 2022 Dec 14.
PubMed 36693025Drossman DA, Tack J, Ford AC, Szigethy E, Tornblom H, Van Oudenhove L. Neuromodulators for Functional Gastrointestinal Disorders (Disorders of Gut-Brain Interaction): A Rome Foundation Working Team Report. Gastroenterology. 2018 Mar;154(4):1140-1171.e1. doi: 10.1053/j.gastro.2017.11.279. Epub 2017 Dec 22.
PubMed 29274869Duan H, Cai X, Luan Y, Yang S, Yang J, Dong H, Zeng H, Shao L. Regulation of the Autonomic Nervous System on Intestine. Front Physiol. 2021 Jul 14;12:700129. doi: 10.3389/fphys.2021.700129. eCollection 2021.
PubMed 34335306Phillips RJ, Powley TL. Innervation of the gastrointestinal tract: patterns of aging. Auton Neurosci. 2007 Oct 30;136(1-2):1-19. doi: 10.1016/j.autneu.2007.04.005. Epub 2007 May 29.
PubMed 17537681Agusti A, Garcia-Pardo MP, Lopez-Almela I, Campillo I, Maes M, Romani-Perez M, Sanz Y. Interplay Between the Gut-Brain Axis, Obesity and Cognitive Function. Front Neurosci. 2018 Mar 16;12:155. doi: 10.3389/fnins.2018.00155. eCollection 2018.
PubMed 29615850Callaghan B, Furness JB, Pustovit RV. Neural pathways for colorectal control, relevance to spinal cord injury and treatment: a narrative review. Spinal Cord. 2018 Mar;56(3):199-205. doi: 10.1038/s41393-017-0026-2. Epub 2017 Nov 16.
PubMed 29142293Rao M, Gershon MD. The bowel and beyond: the enteric nervous system in neurological disorders. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):517-28. doi: 10.1038/nrgastro.2016.107. Epub 2016 Jul 20.
PubMed 27435372Carabotti M, Scirocco A, Maselli MA, Severi C. The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems. Ann Gastroenterol. 2015 Apr-Jun;28(2):203-209.
PubMed 25830558Browning KN, Travagli RA. Central control of gastrointestinal motility. Curr Opin Endocrinol Diabetes Obes. 2019 Feb;26(1):11-16. doi: 10.1097/MED.0000000000000449.
PubMed 30418187Browning KN, Travagli RA. Central nervous system control of gastrointestinal motility and secretion and modulation of gastrointestinal functions. Compr Physiol. 2014 Oct;4(4):1339-68. doi: 10.1002/cphy.c130055.
PubMed 25428846Ali MK, Saha S, Milkova N, Liu L, Sharma K, Huizinga JD, Chen JH. Modulation of the autonomic nervous system by one session of spinal low-level laser therapy in patients with chronic colonic motility dysfunction. Front Neurosci. 2022 Sep 1;16:882602. doi: 10.3389/fnins.2022.882602. eCollection 2022.
PubMed 36117615Ali MK, Chen JDZ. Roles of Heart Rate Variability in Assessing Autonomic Nervous System in Functional Gastrointestinal Disorders: A Systematic Review. Diagnostics (Basel). 2023 Jan 12;13(2):293. doi: 10.3390/diagnostics13020293.
PubMed 36673103Yuan Y, Ali MK, Mathewson KJ, Sharma K, Faiyaz M, Tan W, Parsons SP, Zhang KK, Milkova N, Liu L, Ratcliffe E, Armstrong D, Schmidt LA, Chen JH, Huizinga JD. Associations Between Colonic Motor Patterns and Autonomic Nervous System Activity Assessed by High-Resolution Manometry and Concurrent Heart Rate Variability. Front Neurosci. 2020 Jan 23;13:1447. doi: 10.3389/fnins.2019.01447. eCollection 2019.
PubMed 32038145
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT06205446
- Acronym / sponsor ID
- IRB112-185-A
- Conditions
- Irritable Bowel Syndrome, Healthy Subjects, Functional Gastrointestinal Disorders, Laryngopharyngeal Reflux
- Keywords
- Heart rate variability, Diaphragmatic breathing, Gut-brain axis dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jan 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.
Patients with disorders of gut-brain interaction (DGBI) often present gastrointestinal symptoms that do not show noticeable irregularities in standard examinations. However, due to unclear causes and a high prevalence rate, this condition often exerts a profound impact on the physical and mental health of patients. The scope of DGBI encompasses conditions such as laryngopharyngeal reflux, functional dyspepsia, and irritable bowel syndrome. Previous research has confirmed that in patients with DGBI, their autonomic nervous system exhibits an imbalance, charact erized by decreased parasympathetic activity and dominant sympathetic activity. Diaphragmatic breathing helps reduce the respiratory rate and can stimulate parasympathetic activity while suppressing sympathetic activity. Hence, it is now officially recommended as an effective adjunct therapy for relieving symptoms of gastroesophageal reflux. Accordingly, this study plans to implement a randomized controlled trial, introducing diaphragmatic breathing to patients with DGBI who exhibit normal results in objective examinations. This work allows evaluate changes in their psychophysical symptoms before and after treatment, as well as alterations in the autonomic nervous system .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal breathing | Experimental | Behavioral: Healthy subjects : abdominal breathing, Behavioral: Laryngopharyngeal reflux disease subjects : abdominal breathing, Behavioral: Dyspepsia subjects : abdominal breathing, Behavioral: Irritable bowel disorder : abdominal breathingThe relationship between respiration and the autonomic nervous system (ANS) is closely intertwined, as the phrenic nerve, responsible for controlling the movement of the diaphragm, is connected to the vagus nerve of the parasympathetic nervous system.The respiratory cycle reflects the balance between the parasympathetic and sympathetic nervous systems in the Autonomic Nervous System (ANS), which can be observed through Heart Rate Variability (HRV). The ANS state shifts from the parasympathetic nervous system to the sympathetic nervous system during inhalation, while it transitions from the sympathetic nervous system to the parasympathetic nervous system during exhalation. In HRV, an increase in heart rate indicates enhanced sympathetic nervous system activity during inhalation, whereas a decrease in heart rate signifies increased parasympathetic nervous system activity during exhalation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- No gastrointestinal symptoms or use of gastrointestinal medication.
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
- Gastroesophageal reflux disease (GERD) is defined as the condition characterized by experiencing symptoms for at least three months (such as hoarseness, sensation of a foreign body in the throat, chronic cough, and frequent throat clearing) occurring at least once a week. Reflux Symptom Index (RSI) is a standardized questionnaire for evaluating laryngopharyngeal reflux. It consists of nine reflux-related symptoms, with severity scores ranging from 0 (no symptoms) to 5 (most severe). A total score exceeding 13 indicates the criteria for inclusion of a patient as having laryngopharyngeal reflux.
- Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Infected with antibiotic resistance.
- Received endotracheal intubation in the past two months .
- Having myocardial ischemia or recently experienced a myocardial infarction.
- Unable to collaborate.
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 |
|---|---|---|
| Healthy subjects : abdominal breathingThe guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms. | Behavioural | abdominal breathing |
| Laryngopharyngeal reflux disease subjects : abdominal breathingThe guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms. | Behavioural | abdominal breathing |
| Dyspepsia subjects : abdominal breathingThe guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms. | Behavioural | abdominal breathing |
| Irritable bowel disorder : abdominal breathingThe guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms. | Behavioural | abdominal breathing |
Primary outcome
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 14 Score - Baseline Score).
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days
Time frame: Baseline and day 14
Possible scores range from 1 (Never) to 5 (Always) 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days
Time frame: Baseline and day 14
Possible scores range from 1 (Never) to 3 (4~7days) 0=Never 1=1 day 2=2~3days 3=4~7days Change = (day 14 Score - Baseline Score).
Change from Baseline on the Reflux Symptom Index (RSI) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (no symptoms) to 5 (most severe) 0= No Problem 1=very slight 2=slight 3=About medium 4=moderate to severe 5=Severe Problem Change = (day 14 Score - Baseline Score).
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days
Time frame: Baseline and day 14
Possible scores range from 1 (No pain) to 4 (Worst possible pain) 1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 14 Score - Baseline Score).
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 14 Score - Baseline Score).
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days
Time frame: Baseline and day 14
Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score).
Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days
Time frame: Baseline and day 14
Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score).
Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days
Time frame: Baseline and day 14
Possible scores range from 1 (Strongly disagree) to 6 (Strongly agree) 1=Strongly agree 2=Moderately agree 3=Mildly agree 4=Mildly disagree 5 =Moderately disagree 6=Strongly disagree Change = (day 14 Score - Baseline Score).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Results publication: PubMed 33493503Margolis KG, Cryan JF, Mayer EA. The Microbiota-Gut-Brain Axis: From Motility to Mood. Gastroenterology. 2021 Apr;160(5):1486-1501. doi: 10.1053/j.gastro.2020.10.066. Epub 2021 Jan 22.
- Results publication: PubMed 27147121Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
- Results publication: PubMed 36693025Wong MW, Hsiao SH, Wang JH, Yi CH, Liu TT, Lei WY, Hung JS, Liang SW, Lin L, Gyawali CP, Chen PR, Chen CL. Esophageal Hypervigilance and Visceral Anxiety Contribute to Symptom Severity of Laryngopharyngeal Reflux. Am J Gastroenterol. 2023 May 1;118(5):786-793. doi: 10.14309/ajg.0000000000002151. Epub 2022 Dec 14.
- Results publication: PubMed 29274869Drossman DA, Tack J, Ford AC, Szigethy E, Tornblom H, Van Oudenhove L. Neuromodulators for Functional Gastrointestinal Disorders (Disorders of Gut-Brain Interaction): A Rome Foundation Working Team Report. Gastroenterology. 2018 Mar;154(4):1140-1171.e1. doi: 10.1053/j.gastro.2017.11.279. Epub 2017 Dec 22.
- Results publication: PubMed 34335306Duan H, Cai X, Luan Y, Yang S, Yang J, Dong H, Zeng H, Shao L. Regulation of the Autonomic Nervous System on Intestine. Front Physiol. 2021 Jul 14;12:700129. doi: 10.3389/fphys.2021.700129. eCollection 2021.
- Results publication: PubMed 17537681Phillips RJ, Powley TL. Innervation of the gastrointestinal tract: patterns of aging. Auton Neurosci. 2007 Oct 30;136(1-2):1-19. doi: 10.1016/j.autneu.2007.04.005. Epub 2007 May 29.
- Results publication: PubMed 29615850Agusti A, Garcia-Pardo MP, Lopez-Almela I, Campillo I, Maes M, Romani-Perez M, Sanz Y. Interplay Between the Gut-Brain Axis, Obesity and Cognitive Function. Front Neurosci. 2018 Mar 16;12:155. doi: 10.3389/fnins.2018.00155. eCollection 2018.
- Results publication: PubMed 29142293Callaghan B, Furness JB, Pustovit RV. Neural pathways for colorectal control, relevance to spinal cord injury and treatment: a narrative review. Spinal Cord. 2018 Mar;56(3):199-205. doi: 10.1038/s41393-017-0026-2. Epub 2017 Nov 16.
- Results publication: PubMed 27435372Rao M, Gershon MD. The bowel and beyond: the enteric nervous system in neurological disorders. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):517-28. doi: 10.1038/nrgastro.2016.107. Epub 2016 Jul 20.
- Results publication: PubMed 25830558Carabotti M, Scirocco A, Maselli MA, Severi C. The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems. Ann Gastroenterol. 2015 Apr-Jun;28(2):203-209.
- Results publication: PubMed 30418187Browning KN, Travagli RA. Central control of gastrointestinal motility. Curr Opin Endocrinol Diabetes Obes. 2019 Feb;26(1):11-16. doi: 10.1097/MED.0000000000000449.
- Results publication: PubMed 25428846Browning KN, Travagli RA. Central nervous system control of gastrointestinal motility and secretion and modulation of gastrointestinal functions. Compr Physiol. 2014 Oct;4(4):1339-68. doi: 10.1002/cphy.c130055.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy subjects : abdominal breathing, Laryngopharyngeal reflux disease subjects : abdominal breathing and Dyspepsia subjects : abdominal breathing in people with Irritable Bowel Syndrome and Healthy Subjects, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 11 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: finished, as of the sponsor's last update on 24 Feb 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 Taiwan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days (time frame: Baseline and day 14). The study lists 12 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 NCT06205446, which also lists 45 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 Feb 2025.