Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: Diagnosed GastroDuodenal Ulcer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A : Proton Pump Inhibitors<br>Patients are given proton pump inhibitors tablets once a day | Drug: Esomeprazole<br>* Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan<br>* Other names: Nexium;|
| Placebo Comparator: B: Placebo<br>Patients are given a placebo instead of proton pump inhibitors active drug | Drug: Placebo<br>* Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall symptom relief during the 4 weeks of treatment | Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score | 30 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days without dyspepsia | the number of days with SF-LDQ score <1 | 30 days after inclusion | 
| quality of life assessment | quality of life assessment ccording to the SF-36 score | 30 days after inclusion | 
| Patients satisfaction of the treatment | Patients satisfaction according to Likert score | 30 days after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, Proton Pump Inhibitors, dyspepsia