Gastroesophageal Reflux
Conditions
Interventions
This is a double-blind, parallel-group, randomized clinical trial. 20 patients will be allocated into two intervention groups (ratio 1:1), which will receive different therapeutic regimens. One of the
D02.886.640.074.625
Sponsors
Universidade Federal da Fronteira Sul
Universidade Federal da Fronteira Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age greater than or equal to 18 years; both genders; body mass index between 18.5 and 39.9 kg/m2; chief complaint of heartburn (current if not on treatment or controlled with proton pump inhibitor); diagnosis of sliding hiatal hernia (2 cm or more) confirmed by digestive endoscopy
Exclusion criteria
Exclusion criteria: Not having at least three meals a day regularly, including breakfast, lunch and dinner; cognition and communication difficulties; esophagogastric surgery of any nature; pregnant and lactating women; women in the fertile period without using a contraceptive method; alcohol or tobacco abuse (>10 cigarettes/day); decompensated systemic disease (arterial hypertension, diabetes mellitus, cirrhosis, chronic renal failure, lung disease and any infectious condition); not having heartburn after 5 days of discontinuing the proton pump inhibitor (PPI), if using it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of the study is the control of heartburn, which will be evaluated through the frequency and severity of episodes during the intervention, measured by self-completed diary and questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary outcome, adherence to treatment will be evaluated, measured through the diary, which should contain every time the capsules were administered. | — |
Countries
Brazil
Contacts
Public ContactEduardo Mesa Casa
Universidade Federal da Fronteira Sul
Outcome results
None listed