Dyspepsia
Conditions
Keywords
fasting, Proton Pump Inhibitors, dyspepsia
Brief summary
evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.
Detailed description
evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo. The study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.
Interventions
DRUGEsomeprazole
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
DRUGPlacebo
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
the objective is to evaluate the interest of proton pump inhibitors in subjects with or without GI symptoms who intend to observe fasting in Ramadan. We will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan as compared to placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
* Diagnosed GastroDuodenal Ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall symptom relief during the 4 weeks of treatment | 30 days after inclusion | Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of days without dyspepsia | 30 days after inclusion | the number of days with SF-LDQ score \<1 |
| quality of life assessment | 30 days after inclusion | quality of life assessment ccording to the SF-36 score |
| Patients satisfaction of the treatment | 30 days after inclusion | Patients satisfaction according to Likert score |
Countries
Tunisia
Outcome results
None listed