DyspepsiaPhase 1/2NCT05287633
Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
A Phase 1/2 study testing Esomeprazole in people with Dyspepsia, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Jan 2020to 30 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Diagnosed GastroDuodenal Ulcer
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Monastir, 5000
About this study
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.
Read the 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.
- Conditions
- Dyspepsia
- Being tested
- Esomeprazole, Placebo
- Keywords
- fasting, Proton Pump Inhibitors, dyspepsia
- Medical subject headings
- Dyspepsia, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
PlaceboDrug
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
| Study group | Role | What they receive |
|---|---|---|
| A : Proton Pump Inhibitors | Active comparator | Patients are given proton pump inhibitors tablets once a day Receives: Drug: Esomeprazole |
| B: Placebo | Placebo comparator | Patients are given a placebo instead of proton pump inhibitors active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after inclusion
Secondary outcomes (3)
number of days without dyspepsia
the number of days with SF-LDQ score <1
Measured: 30 days after inclusion
quality of life assessment
quality of life assessment ccording to the SF-36 score
Measured: 30 days after inclusion
Patients satisfaction of the treatment
Patients satisfaction according to Likert score
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start20 Jan 2020
- Primary completion15 Dec 2020
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287633
- Sponsor's protocol ID
- PPI
- Status last verified
- Feb 2025
- First submitted
- 10 Sep 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41120363
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
- ClinicalTrials.gov ID
- NCT05287633
- Acronym / sponsor ID
- PPI
- Conditions
- Dyspepsia
- Keywords
- fasting, Proton Pump Inhibitors, dyspepsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A : Proton Pump Inhibitors | Active comparator | Drug: EsomeprazolePatients are given proton pump inhibitors tablets once a day |
| B: Placebo | Placebo comparator | Drug: PlaceboPatients are given a placebo instead of proton pump inhibitors active drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Diagnosed GastroDuodenal Ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsomeprazoleAlso: NexiumPatients are given a box of capsules of which they take 1capsule/day during the month of ramadan | Drug | A : Proton Pump Inhibitors |
| PlaceboPatients are given a box of capsules of which they take 1capsule/day during the month of ramadan | Drug | B: Placebo |
Primary outcome
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
3 secondary outcomes
number of days without dyspepsia
Time frame: 30 days after inclusion
quality of life assessment
Time frame: 30 days after inclusion
Patients satisfaction of the treatment
Time frame: 30 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Derived from this study: PubMed 41120363Hadrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semir Nouira, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esomeprazole in people with Dyspepsia, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall symptom relief during the 4 weeks of treatment (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.