Behavioral Therapy in Patients With Rumination

Not Applicable

Completed

Conditions: Functional Gastrointestinal Disorders

Interventions: Behavioral: Behavioral therapy
Behavioral: Physiotherapy

Registration Number: NCT05232097

Lead Sponsor: Helsinki University Central Hospital

Brief Summary: The study aim is to diagnose patients with the rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles.

Before referral to the study, gastroscopy, esophageal hgh-resolution manometry and 24-hour esophageal pH and impedance monitoring are required to rule out other esophageal conditions.

Twenty Finnish speaking, 15-70 years old patients will be enrolled in this open study. All patients will visit the gastroenterologist at onset of the study and at 6 months. All patients will be referred to the speech therapist for five one-hour sessions consisting of diaphragmatic belching exercises and to the physiotherapist for two one-hour sessions consisting of exercises to relax tensed thoracic and abdominal muscles. All patients will also visit once the psychologist and dietician.

Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases at onset and at the 6-month control. Health-related quality of life, depression, anxiety, functional capacity will be evaluated by specific questionnaires at onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.

Detailed Description: Background: Rumination is a subconscious but a volitional, behavioral disorder. Contraction of the abdominal muscles results in an increase of abdominal pressure and a subsequent regurgitation of recently ingested food, followed by rechewing, reswallowing or spitting (1). The diagnosis is based on the Rome IV criteria for functional gastrointestinal disorders and esophageal high-resolution manometry (1, 2). Behavioral therapy consisting of diaphragmatic breathing exercises has proven efficient in these patients (3, 4). Psychophysical physiotherapy was effective in a published patient case (5).

Aim: The study aim is to diagnose patients with rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy. The primary aim is a reduction of two points ore more in the rumination frequency measured by the Rome IV questionnaire for adult functional gastrointestinal diseases (6). Secondary aims are improved esophageal high-resolution manometry, health-related quality of life, and functional capacity and reduced anxiety and depression scores.

Patients: 20 Finnish speaking, 15-70 years old patients with rumination symptoms fulfilling the Rome IV criteria will be enrolled in this open study. Before referral to Helsinki University Central Hospital, gastroscopy, esophageal high-resolution manometry and esophageal 24-hour pH and impedance monitoring are required. Adolescents of 15 to 17 years old are referred to the childrens' gastroenterologist and adults 18 years or older are referred to the gastroenterologist. The inclusion criteria consist of rumination symtoms fulfilling the Rome IV criteria but esophageal high-resolution manometry may be negative because rumination cannot be always provoked during the study.The exclusion criteria comprise eating disorder, BMI \<14, pregnancy, cognitive or other disorder that disallows behavioral therapy

Methods: Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases in all patients. Health-related quality of life will be evaluated by 15D, a 15-dimensional measure of health-related quality of life, depression by Beck Depression Inventory (BDI), anxiety by the Beck Anxiety Inventory (BAI), and functional capacity by WHODAS 2.0, World Health Organization disability assesment schedule 2.0 in the patients 18 years or older (7-10). In the patients 15-17 years old, health-related qualiy of life will be evaluated by 16D, a sixteen-dimensional health-related measure for adolescents (11). All questionnaires will be carried out at the onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.

After the baseline visit to the gastroenterologist, patients will be sent to the speech therapist for five, one-hour sessions consisting of diaphragmatic breathing exercises and to a psychophysical physiotherapist for two one-hours sessions aiming at body-awareness to sense tensed thoracic and abdominal muscles and to relax them through guided exercises. Patients will continue these exercises at home during meals. All patient l visit the psychologist and dietician once to rule out eating disorders and other psychopathological conditions and will be referred to the psychiatrist when necessary. Esophageal high-resolution manometry will be performed at the 6-month control.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

Inclusion Criteria

Rome IV criteria for rumination syndrome fulfilled
gastroscopy, esophageal HR-manometry and 24-hour pH-impedance monitoring performed before referral to study

Exclusion Criteria

eating disorder, BMI <14, pregnancy, cognitive or other disorder that disallows behavioral therapy

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral therapy	Behavioral therapy	Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles
Behavioral therapy	Physiotherapy	Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles

Primary Outcome Measures

Name	Time	Method
Rumination Score (Self-perceived Rumination Frequency)	6-month control	Rumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: "In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time". Scale 0-8, the highest score indicating highest frequency of rumination.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher	6-month control	Number of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination.
Anxiety Score (BAI)	6-month control	Beck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Weight	6-month control	Weight in kilograms
Health-related Quality of Life (15D)	6-month control	The 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead).
Functional Capacity (WHODAS 2.)	6-month control	WHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding \& communicating, Mobility- moving \& getting around, Self-care- hygiene, dressing, eating \& staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work \& school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability.
Depression Score (BDI)	6-month control	Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.