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Completed

NCT Number: NCT05287633

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.

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Key information

Conditions

Dyspepsia Behavior Fasting Feeding Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • Diagnosed GastroDuodenal Ulcer

Treatment and study plan

Esomeprazole

Drug

Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan

Other names: Nexium

Placebo

Drug

Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan

Primary outcomes

  1. Overall symptom relief during the 4 weeks of treatment

    Time frame: 30 days after inclusion

    Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score

Secondary outcomes

  1. number of days without dyspepsia

    Time frame: 30 days after inclusion

    the number of days with SF-LDQ score <1

  2. quality of life assessment

    Time frame: 30 days after inclusion

    quality of life assessment ccording to the SF-36 score

  3. Patients satisfaction of the treatment

    Time frame: 30 days after inclusion

    Patients satisfaction according to Likert score

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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