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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A : Proton Pump Inhibitors | Active Comparator | Patients are given proton pump inhibitors tablets once a day |
|
| B: Placebo | Placebo Comparator | Patients are given a placebo instead of proton pump inhibitors active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan |
|
| 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 |
| 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 |
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Inclusion Criteria:
-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, Professor | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia | Monastir | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120363 | Derived | Hadrich S, Lamti F, Trabelsi I, Dhaoui R, Ben Abdewahed M, Sekma A, Neffati F, Boukadida L, Yaakoubi H, Jaballah R, Bakir A, Youssef R, Zorgati A, Bel Haj Ali K, Beltaief K, Dridi Z, Ben Hamda K, Jomaa W, Chamtouri I, Bendaya Y, Bouchoucha M, Ben Hafaeidh S, Razgallah R, Bouida W, Grissa MH, Sriha A, Khedher S, Khochtali I, Sakly N, Ben Soltane H, Hassine M, Boubaker H, Boukef R, Msolli MA, Nouira S. Randomized trial of the effect of esomeprazole on functional dyspepsia during Ramadan fasting. Sci Rep. 2025 Oct 21;15(1):36535. doi: 10.1038/s41598-025-17532-x. |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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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.
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| Placebo | Drug | Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan |
|
| 30 days after inclusion |
| Patients satisfaction of the treatment | Patients satisfaction according to Likert score | 30 days after inclusion |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |