RuminationNCT03912636
Role of Vagal Tone in Rumination Syndrome
A study testing Diaphragmatic breathing, Deep Slow Breathing and Normal breathing in people with Rumination, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Rumination syndrome is a condition in which people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach, rechew it, and then either re-swallow it or spit it out. The mechanism of the disease is not well understood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination
- What is being tested?
- Diaphragmatic breathing, Deep Slow Breathing and Normal breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 31 Mar 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (HVs)
- 18-65 years old
- No history of any gastrointestinal (GI) symptoms in the 3 months prior to the study.
- No medications 3 months prior to the study
- Rumination patients
- 18-65 years old
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- Fulfilling ROME IV clinical criteria for rumination
- Confirmed rumination syndrome by High Resolution Impedance Monometry within 12 months prior to the study
- No history of performing DiaB as a therapy for rumination syndrome.
- No medications which may affect vagal tone, the number of rumination episodes and GI motility 3 months prior to the study. (i.e. opioids, Baclofen , anticholinergics drugs, prokinetics, beta-blockers)
Who cannot join
- Pregnant or lactating women
- History of GI surgeries apart from appendectomy
- Alcohol or substance abuse, mental health illness
- Inability to obtain informed consent
- Non-fluent English speakers
- Participants with food intolerances or allergies that would not be able to take in the test meal (McDonalds Big Mac meal)
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- Major comorbidities such as significant cardiac/pulmonary disease, cancer, life-threatening conditions or other life-limiting conditions
- Evidence of relevant organic diseases. (in endoscopy, CT.)
- Evidence of major esophageal motility disorders (Chicago classification ver3.0) (21)
- Known allergy to ECG electrodes or latex
- History of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rumination Syndrome: Role of Vagal Tone and Effect of Respiratory Manoeuvres on Severity and Frequency of Rumination
Rumination syndrome is a condition in which people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach, rechew it, and then either re-swallow it or spit it out. The mechanism of the disease is not well understood. The investigators believe that discomfort in the stomach during and immediately after meals may be an important factor for this disease. The reason for such discomfort can be due to an alteration of nervous regulation of the stomach. The investigators can study the nervous regulation that affects the stomach and other parts of the body by analysing in detail an electrocardiogram that is performed continuously for several hours. From this analysis, The investigators can study a parameter called cardiac vagal tone (CVT).
Diaphragmatic breathing (DiaB) is a respiratory exercise, in which people mainly move their abdomen to breath. DiaB is a common treatment for rumination syndrome. Patients doing DiaB can reduce the number of rumination episodes. The mechanism by which DiaB improves rumination is unknown. There is another type of breathing called slow deep breathing (SlowDB), in which people mainly breathe with their chest. SlowDB is used as a therapy for increased pain in the food pipe (oesophagus) and it might also be effective on rumination syndrome. The investigators believe that both DiaB and SlowDB can improve rumination, by modifying the nervous control of the stomach (that the investigators can monitor by measuring continuously cardiac vagal tone (CVT)). The aims of the study are to investigate the association between gastric discomfort during a meal, CVT variations (measured with the electrocardiogram during the meal) and the severity of rumination episodes. The investigators will also study how DiaB and SlowDB can modify this variable during the test. In a second step, The investigators will assess the clinical effect of respiratory exercises (DiaB and SlowDB) on the severity and frequency of regurgitations in patients diagnosed with rumination syndrome.
Read more
Method This research consists of two separate studies.
- Study1 (to investigate the mechanism of rumination syndrome) 10 healthy volunteers and 10 rumination patients will join Study1 on 3 separate days. On each visit, the investigators will place electrocardiogram sensors and a belt that can measure the thorax or abdominal movement. All subjects will get instructions to perform SlowDB or DiaB, answer some questionnaires, eat the test meal, perform normal breathing/DiaB/SlowDB for 15 minutes, and stay quietly on the chair for 3 hours.
- Study 2 (to assess the effect of DiaB and SlowDB on rumination syndrome) 10 patients with rumination syndrome will join Study 2. On the first visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform either DiaB or SlowDB. After the first visit, subjects perform DiaB or SlowDB during 15 minutes after every meal for 4 weeks. On the second visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform the other respiratory exercise. After a 2-week break, subjects will perform the other respiratory exercise for the next 4 weeks. On the last visit, subjects will have the test meal and answer the symptom questionnaire 1 hour after the meal.
- Conditions
- Rumination
- Being tested
- Diaphragmatic breathing, Deep Slow Breathing, Normal breathing
- Keywords
- cardiac vagal tone, deep breathing, diaphragmatic breathing, vagal nerve, vagal tone, cognitive behavioral therapy, visceral hypersensitivity
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathingBehavioural
Subjects will perform Diaphragmatic breathing after the test meal.
Deep Slow BreathingBehavioural
Subjects will perform Deep Slow Breathing after the test meal.
Normal breathingBehavioural
Subjects will perform Normal Breathing (as a control) after the test meal as a control.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing in healthy volunteers in study1 | Active comparator | Healthy volunteers will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Diaphragmatic breathing |
| Diaphragmatic breathing in rumination patients in study1 | Active comparator | Rumination patients will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Diaphragmatic breathing |
| Deep slow breathing in healthy volunteers in study1 | Active comparator | Healthy volunteers will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Deep Slow Breathing |
| Deep slow breathing in rumination patients in study1 | Active comparator | Rumination patients will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Deep Slow Breathing |
| Normal breathing in healthy volunteers in study1 | Placebo comparator | healthy volunteers will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Normal breathing |
| Normal breathing in rumination patients in study1 | Placebo comparator | rumination patients will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone. Receives: Behavioral: Normal breathing |
| Diaphragmatic breathing in study 2; cross over test | Active comparator | Rumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination. Receives: Behavioral: Diaphragmatic breathing |
| Deep slow breathing in study 2; cross over test | Active comparator | Rumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination. Receives: Behavioral: Deep Slow Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of changes in cardiac vagal tone (CVT) calculated from R-R intervals in electrocardiogram between healthy volunteers and rumination patients in Study 1
CVT is calculated from R-R intervals in electrocardiogram and measured on a validated linear vagal scale, where 0 represents full atropinisation. The investigators will continuously measure CVT during the 15-min baseline period, 30-min meal period, 15-min intervention period, and 3-h postprandial period.
Measured: from baseline to 3-hour postprandial period.
Comparison of changes in Meal-induced discomfort scores between healthy volunteers and rumination patients in Study 1
This score consists of 3 visual analog scales (VAS) of the level of nausea, fullness and epigastric discomfort. Each scale is graded from 0 to 5, where score 0 represents no perception and score 5 represents an extremely uncomfortable sensation. A Total score can vary between 0 and 15.
Measured: baseline, every 5 minutes during the 30-min meal period, every 30 minutes during the 3-hour postprandial period
Comparison of changes in the number of rumination episodes between Diaphragmatic breathing group and Deep slow breathing group in Study 2
Subjects will count the number of rumination episodes during 1-hour postprandial period in the laboratory.
Measured: from baseline to after the 4-week intervention period
Secondary outcomes (4)
Comparison of changes in cardiac vagal tone (CVT) calculated from R-R intervals in electrocardiogram among 3 respiratory exercises in Study 1
CVT is calculated from R-R intervals in electrocardiogram and measured on a validated linear vagal scale, where 0 represents full atropinisation. The investigators will continuously measure CVT during the 15-min baseline period, 30-min meal period, 15-min intervention period, and 3-h postprandial period.
Measured: from baseline to 3-hour postprandial period.
Comparison of the number of rumination episodes among 3 respiratory exercises in rumination patients in Study 1
The subjects will count the number of rumination episodes the 15-min baseline period, 30-min meal period, 15-min intervention period, and the first 1-hour postprandial period.
Measured: Baseline, meal period, 15-min intervention period, and first 1-hour postprandial period
Comparison of Treatment Evaluation scores in 2 groups in Study 2
The subjects will rate the perception of their complaints compared to the pre-treatment period from -3 to +3: -3 totally unbearable, -2 much worse, -1 slightly worse, 0 no change, +1 slightly better, +2 much better, and +3 totally resolved).
Measured: Baseline and every week during the 4-week intervention period
Comparison of changes in Meal-induced discomfort scores among 3 respiratory exercises in Study 1
This score consists of 3 visual analog scales (VAS) of the level of nausea, fullness and epigastric discomfort. Each scale is graded from 0 to 5, where score 0 represents no perception and score 5 represents an extremely uncomfortable sensation. Total scores can vary between 0 and 15.
Measured: baseline, every 5 minutes during the 30-min meal period, every 30 minutes during the 3-hour postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- In study 1 for the pathophysiology of rumination syndrome, the investigators will recruit 10 healthy volunteers and 10 patients. In study 2 for the treatment, the investigators will recruit 10 patients and perform the cross-over test, in which the patients will perform 2 breathing exercises and the investigators will compare the effects.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mays Jawad, Study chair, Joint Research Management Office, Queen Mary, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912636
- Sponsor's protocol ID
- 19/ss/0054
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share the data with other researchers outside of our team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rumination Syndrome: Role of Vagal Tone and Effect of Respiratory Manoeuvres on Severity and Frequency of Rumination
- ClinicalTrials.gov ID
- NCT03912636
- Acronym / sponsor ID
- 19/ss/0054
- Conditions
- Rumination
- Keywords
- cardiac vagal tone, deep breathing, diaphragmatic breathing, vagal nerve, vagal tone, cognitive behavioral therapy, visceral hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 11 Apr 2019 (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.
Rumination syndrome is a condition in which people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach, rechew it, and then either re-swallow it or spit it out. The mechanism of the disease is not well understood. The investigators believe that discomfort in the stomach during and immediately after meals may be an important factor for this disease. The reason for such discomfort can be due to an alteration of nervous regulation of the stomach. The investigators can study the nervous regulation that affects the stomach and other parts of the body by analysing in detail an electrocardiogram that is performed continuously for several hours. From this analysis, The investigators can study a parameter called cardiac vagal tone (CVT).
Diaphragmatic breathing (DiaB) is a respiratory exercise, in which people mainly move their abdomen to breath. DiaB is a common treatment for rumination syndrome. Patients doing DiaB can reduce the number of rumination episodes. The mechanism by which DiaB improves rumination is unknown. There is another type of breathing called slow deep breathing (SlowDB), in which people mainly breathe with their chest. SlowDB is used as a therapy for increased pain in the food pipe (oesophagus) and it might also be effective on rumination syndrome. The investigators believe that both DiaB and SlowDB can improve rumination, by modifying the nervous control of the stomach (that the investigators can monitor by measuring continuously cardiac vagal tone (CVT)). The aims of the study are to investigate the association between gastric discomfort during a meal, CVT variations (measured with the electrocardiogram during the meal) and the severity of rumination episodes. The investigators will also study how DiaB and SlowDB can modify this variable during the test. In a second step, The investigators will assess the clinical effect of respiratory exercises (DiaB and SlowDB) on the severity and frequency of regurgitations in patients diagnosed with rumination syndrome.
Method This research consists of two separate studies.
- Study1 (to investigate the mechanism of rumination syndrome) 10 healthy volunteers and 10 rumination patients will join Study1 on 3 separate days. On each visit, the investigators will place electrocardiogram sensors and a belt that can measure the thorax or abdominal movement. All subjects will get instructions to perform SlowDB or DiaB, answer some questionnaires, eat the test meal, perform normal breathing/DiaB/SlowDB for 15 minutes, and stay quietly on the chair for 3 hours.
- Study 2 (to assess the effect of DiaB and SlowDB on rumination syndrome) 10 patients with rumination syndrome will join Study 2. On the first visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform either DiaB or SlowDB. After the first visit, subjects perform DiaB or SlowDB during 15 minutes after every meal for 4 weeks. On the second visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform the other respiratory exercise. After a 2-week break, subjects will perform the other respiratory exercise for the next 4 weeks. On the last visit, subjects will have the test meal and answer the symptom questionnaire 1 hour after the meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- In study 1 for the pathophysiology of rumination syndrome, the investigators will recruit 10 healthy volunteers and 10 patients. In study 2 for the treatment, the investigators will recruit 10 patients and perform the cross-over test, in which the patients will perform 2 breathing exercises and the investigators will compare the effects.
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing in healthy volunteers in study1 | Active comparator | Behavioral: Diaphragmatic breathingHealthy volunteers will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Diaphragmatic breathing in rumination patients in study1 | Active comparator | Behavioral: Diaphragmatic breathingRumination patients will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Deep slow breathing in healthy volunteers in study1 | Active comparator | Behavioral: Deep Slow BreathingHealthy volunteers will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Deep slow breathing in rumination patients in study1 | Active comparator | Behavioral: Deep Slow BreathingRumination patients will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Normal breathing in healthy volunteers in study1 | Placebo comparator | Behavioral: Normal breathinghealthy volunteers will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Normal breathing in rumination patients in study1 | Placebo comparator | Behavioral: Normal breathingrumination patients will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone. |
| Diaphragmatic breathing in study 2; cross over test | Active comparator | Behavioral: Diaphragmatic breathingRumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination. |
| Deep slow breathing in study 2; cross over test | Active comparator | Behavioral: Deep Slow BreathingRumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy volunteers (HVs)
- Rumination patients
Key exclusion criteria (11 listed)
- Pregnant or lactating women
- History of GI surgeries apart from appendectomy
- Alcohol or substance abuse, mental health illness
- Inability to obtain informed consent
- Non-fluent English speakers
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 |
|---|---|---|
| Diaphragmatic breathingSubjects will perform Diaphragmatic breathing after the test meal. | Behavioural | Diaphragmatic breathing in healthy volunteers in study1, Diaphragmatic breathing in rumination patients in study1, Diaphragmatic breathing in study 2; cross over test |
| Deep Slow BreathingSubjects will perform Deep Slow Breathing after the test meal. | Behavioural | Deep slow breathing in healthy volunteers in study1, Deep slow breathing in rumination patients in study1, Deep slow breathing in study 2; cross over test |
| Normal breathingSubjects will perform Normal Breathing (as a control) after the test meal as a control. | Behavioural | Normal breathing in healthy volunteers in study1, Normal breathing in rumination patients in study1 |
Primary outcome
Comparison of changes in cardiac vagal tone (CVT) calculated from R-R intervals in electrocardiogram between healthy volunteers and rumination patients in Study 1
Time frame: from baseline to 3-hour postprandial period.
CVT is calculated from R-R intervals in electrocardiogram and measured on a validated linear vagal scale, where 0 represents full atropinisation. The investigators will continuously measure CVT during the 15-min baseline period, 30-min meal period, 15-min intervention period, and 3-h postprandial period.
Comparison of changes in Meal-induced discomfort scores between healthy volunteers and rumination patients in Study 1
Time frame: baseline, every 5 minutes during the 30-min meal period, every 30 minutes during the 3-hour postprandial period
This score consists of 3 visual analog scales (VAS) of the level of nausea, fullness and epigastric discomfort. Each scale is graded from 0 to 5, where score 0 represents no perception and score 5 represents an extremely uncomfortable sensation. A Total score can vary between 0 and 15.
Comparison of changes in the number of rumination episodes between Diaphragmatic breathing group and Deep slow breathing group in Study 2
Time frame: from baseline to after the 4-week intervention period
Subjects will count the number of rumination episodes during 1-hour postprandial period in the laboratory.
4 secondary outcomes
Comparison of changes in cardiac vagal tone (CVT) calculated from R-R intervals in electrocardiogram among 3 respiratory exercises in Study 1
Time frame: from baseline to 3-hour postprandial period.
Comparison of the number of rumination episodes among 3 respiratory exercises in rumination patients in Study 1
Time frame: Baseline, meal period, 15-min intervention period, and first 1-hour postprandial period
Comparison of Treatment Evaluation scores in 2 groups in Study 2
Time frame: Baseline and every week during the 4-week intervention period
Comparison of changes in Meal-induced discomfort scores among 3 respiratory exercises in Study 1
Time frame: baseline, every 5 minutes during the 30-min meal period, every 30 minutes during the 3-hour postprandial period
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 21 Apr 2022.
- Individual participant dataSharing planned: No. The investigators will not share the data with other researchers outside of our team.
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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.
Mays Jawad study chair
Joint Research Management Office, Queen Mary, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing, Deep Slow Breathing and Normal breathing in people with Rumination, run by Queen Mary University of London at 1 site in United Kingdom.
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 10 inclusion and 11 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 21 Apr 2022. 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 United Kingdom. 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?
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?
Comparison of changes in cardiac vagal tone (CVT) calculated from R-R intervals in electrocardiogram between healthy volunteers and rumination patients in Study 1 (time frame: from baseline to 3-hour postprandial period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2022.