Effect of cognitive behavior therapy and fluoxetine on symptoms improvement in patients with troublesome supragastric belching: a randomized placebo-controlled study

Phase 3

Recruiting

• Conditions: Supragastric belching; Supragastric belching, belch, fluoxetine, diaphragmatic breathing, cognitive behavioral therapy

• Registration Number: TCTR20210122006
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-22
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 63

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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