Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

NCT ID: NCT05287633

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2024-12-30

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.

Conditions

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Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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A : Proton Pump Inhibitors

Patients are given proton pump inhibitors tablets once a day

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

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

B: Placebo

Patients are given a placebo instead of proton pump inhibitors active drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Esomeprazole

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Diagnosed GastroDuodenal Ulcer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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

Monastir, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type DERIVED
PMID: 41120363 (View on PubMed)

Other Identifiers

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PPI

Identifier Type: -

Identifier Source: org_study_id

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