N/A
N=11
Behavioral Therapy in Patients With Rumination
Functional Gastrointestinal Disorders
Bottom Line
View on ClinicalTrials.gov: NCT05232097 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Rumination Score (Self-perceived Rumination Frequency) — 4 score on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral therapy (Behavioral); Physiotherapy (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rumination Score (Self-perceived Rumination Frequency) |
4 | 0.005 sig |
| SECONDARY Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher |
6 | 0.11 |
| SECONDARY Health-related Quality of Life (15D) |
0.845 | 0.060 |
| SECONDARY Functional Capacity (WHODAS 2.) |
11 | 0.865 |
| SECONDARY Depression Score (BDI) |
7 | 0.149 |
| SECONDARY Anxiety Score (BAI) |
15 | 1.000 |
| SECONDARY Weight |
71 | 0.102 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05232097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.