Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: Esomeprazole; Drug: 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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-

Exclusion Criteria:

• Diagnosed GastroDuodenal Ulcer

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, Professor, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: fasting; dyspepsia; Proton Pump Inhibitors
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: PPI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No