Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

NCT05287633 | Completed Phase 1

• 1 other identifier: PPI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Keywords

fasting; Proton Pump Inhibitors; dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• number of days without dyspepsia

  30 days after inclusion

• quality of life assessment

  30 days after inclusion

• Patients satisfaction of the treatment

  30 days after inclusion

Study Arms (2)

A : Proton Pump Inhibitors

ACTIVE COMPARATOR

Patients are given proton pump inhibitors tablets once a day

Drug: Esomeprazole

B: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Esomeprazole DRUG

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

Also known as: Nexium

A : Proton Pump Inhibitors

Placebo DRUG

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

B: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Diagnosed GastroDuodenal Ulcer

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

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

Monastir, 5000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 41120363 DERIVED

MeSH Terms

Conditions

Dyspepsia; Fasting

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Semir Nouira, Professor

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: March 18, 2022
• Study Start: January 20, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

TU (1)