Supragastric belching Supragastric belching, belch, fluoxetine, diaphragmatic breathing, cognitive behavioral therapy
Conditions
Interventions
Lactose 600 mg in white capsule given 1 tablet once daily for 2 weeks and then if the patients still have disturbing belching symptoms, or VAS has not improved more than 50%, increase the dosage to 2
Placebo Comparator Drug,Active Comparator Drug,Experimental Behavioral
Placebo,Fluoxetine,Cognitive behavioral therapy
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Disturbing belching with frequency more than 3 days/week more than 3 months with onset of symptom beginning more than 6 months before enrollment and disturbing symptom with visual analog scale more than 6 after run-in period 2. Confirmed diagnosis of excessive pathological SGB by using ambulatory 24-hr multichannel intraluminal impedance-pH monitoring
Exclusion criteria
Exclusion criteria: 1. Current selective serotonin receptors inhibitors (SSRI) user or could not use SSRI due to previous adverse effect 2. Pregnancy or lactation 3. Diagnosed with erosive esophagitis, LA classification C and D or gastric ulcer or esophageal stricture in the past 3 months 4. Current active malignancy 5. Diagnosed with major psychiatric disorders by DSM V criteria: major depressive disorders, schizophrenia, general anxiety disorder, bipolar disorder 6.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the patients with disappearance of disturbing belching symptoms 6 weeks after the start of treatment number of patients,Proportion of the patients with the decrease in belching symptoms more than 50 percent 6 weeks after the start of treatment Visual analog score,Change in belching symptom 6 weeks after the start of treatment Visual analog score | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of the patients with sustained disappearance of disturbing belching symptoms 12 weeks after the start of treatment number of patients,Proportion of the patients with the sustained decrease in belching symptoms more than 50 percent 12 weeks after the start of treatment Visual analog score,Change in belching symptom at end of treatment 12 weeks after the start of treatment Visual analog score,Change in number of supragastric belching events before and after treatment 12 weeks after the start of treatment Number of supragastric belching from 24-hr MII-pH monitoring,Change in esophageal manometric parameters, acid exposure time and mucosal impedance after treatment 12 weeks after the start of treatment High resolution esophageal manometry and 24-hr MII-pH monitoring ,Drug adherence and adverse effects of medication and placebo every visit adherence and adverse effect events | — |
Countries
Thailand
Contacts
Public ContactJarongkorn Sirimongkolkasem
Division of Gastroenterology, Department of Medicine, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society, Bangkok 10330, Thailand
Outcome results
None listed