Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Phase 1

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Placebo; Drug: Esomeprazole

• Registration Number: NCT05287633
• Lead Sponsor: University of Monastir

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.

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-09-10
• Primary Completion: 2020-12-15
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-18
• Study Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Exclusion Criteria

• Diagnosed GastroDuodenal Ulcer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Placebo	Placebo	Patients are given a placebo instead of proton pump inhibitors active drug
A : Proton Pump Inhibitors	Esomeprazole	Patients are given proton pump inhibitors tablets once a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia; 🇹🇳 Monastir, Tunisia