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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic breathing | Behavioral | Subjects will perform Diaphragmatic breathing after the test meal. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | from baseline to after the 4-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Healthy volunteers (HVs)
Rumination patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mays Jawad | Joint Research Management Office, Queen Mary, University of London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wingate Institue | London | E1 2AJ | United Kingdom |
The investigators will not share the data with other researchers outside of our team.
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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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.
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When the investigators analyze the data, the investigator will be blinded to the conditions of the participants and the types of breathing exercises.
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| 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. |
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| 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. |
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| 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. |
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| Deep Slow Breathing | Behavioral | Subjects will perform Deep Slow Breathing after the test meal. |
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| Normal breathing | Behavioral | Subjects will perform Normal Breathing (as a control) after the test meal as a control. |
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| 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. | 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). | 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. | baseline, every 5 minutes during the 30-min meal period, every 30 minutes during the 3-hour postprandial period |