Role of Vagal Tone in Rumination Syndrome

April 20, 2022 updated by: Queen Mary University of London

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.

Method This research consists of two separate studies.

  1. 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.
  2. 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 Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Rumination patients

    • 18-65 years old
    • 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)

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diaphragmatic breathing in healthy volunteers in study1
Healthy volunteers will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Diaphragmatic breathing after the test meal.
Active Comparator: Diaphragmatic breathing in rumination patients in study1
Rumination patients will perform diaphragmatic breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Diaphragmatic breathing after the test meal.
Active Comparator: Deep slow breathing in healthy volunteers in study1
Healthy volunteers will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Deep Slow Breathing after the test meal.
Active Comparator: Deep slow breathing in rumination patients in study1
Rumination patients will perform deep slow breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Deep Slow Breathing after the test meal.
Placebo Comparator: Normal breathing in healthy volunteers in study1
healthy volunteers will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Normal Breathing (as a control) after the test meal as a control.
Placebo Comparator: Normal breathing in rumination patients in study1
rumination patients will perform normal breathing, and the investigators will investigate changes of cardiac vagal tone.
Subjects will perform Normal Breathing (as a control) after the test meal as a control.
Active Comparator: Diaphragmatic breathing in study 2; cross over test
Rumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination.
Subjects will perform Diaphragmatic breathing after the test meal.
Active Comparator: Deep slow breathing in study 2; cross over test
Rumination patients will perform diaphragmatic breathing in randomized cross-over test. The investigators will compare the effects on rumination.
Subjects will perform Deep Slow Breathing after the test meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.
from baseline to 3-hour 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.
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
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.
from baseline to after the 4-week intervention period

Secondary Outcome Measures

Outcome Measure
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
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.
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
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
Time Frame: Baseline and every week during the 4-week intervention period
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
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. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mays Jawad, Joint Research Management Office, Queen Mary, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators will not share the data with other researchers outside of our team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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