DyspepsiaPhase 4NCT07578402
Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
A Phase 4 study testing Digestive enzyme 325mg and PPI 20 mg + Domperidone 10 mg in people with Dyspepsia and Functioanl Dyspepsia, run by Rakibul Mostafa at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia, Functioanl Dyspepsia, Epigastric Pain Syndrome
- What is being tested?
- Digestive enzyme 325mg and PPI 20 mg + Domperidone 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 May 2026to 28 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or more
- Patients with FD diagnosed according to ROME IV criteria
Who cannot join
- Structural lesion in endoscopy and positive H. pylori status
- History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders
- Psychiatric disorders
- Previous history gastrointestinal surgery
- Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Dhaka Medical College
Dhaka, 1000
Rakibul Mostafa, +8801837031585, rakibmasuk96@gmail.com
About this study
Official title: Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial
The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.
Read more
Participants will:
Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.
- Being tested
- Digestive enzyme 325mg, PPI 20 mg + Domperidone 10 mg
- Keywords
- Dyspepsia, Post parendial distress syndrome (PPDS), Epigastric pain syndrome (EPS), Functional dyspepsia (FD), Disorder of gut brain interaction (DGBI)
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive enzyme 325mgDrug
Digestive enzyme will be given to group A patient
PPI 20 mg + Domperidone 10 mgDrug
Group B patient will get first line treatment only for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Drug: Digestive enzyme 325mg + first line treatment This group will get digestive enzyme 325 mg 3 times daily along with first line treatment (PPI 20 mg twice daily and Prokinetics such domperidone 10mg three time daily) for 1 month Receives: Drug: Digestive enzyme 325mg |
| Group-B | Active comparator | Drug: First line treatment only This group will get first line treatment only ( PPI 20 mg twice daily and prokinetics such as domperidone 10 mg 3 times daily) for 1 month Receives: Drug: PPI 20 mg + Domperidone 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspeptic symptom
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Measured: At baseline and then at week 2 and 4 after randomization
Secondary outcomes (3)
See the effect of digestive enzymes compared to first line treatment only
Effect of digestive enzymes on four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed and compared to first line treatment only by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Measured: At baseline and then at week 2 and 4 after randomization
Adverse events
Patient reported adverse events will be documented
Measured: Through study completion, an average of 1 year
Persistence of symptom improvement or recurrence of dyspeptic symptoms
Persistence of symptom improvement or recurrence of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) after discontinuation of digestive enzymes will be assessed and compared by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Measured: At week 8 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rakibul Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rakibul Mostafa, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578402
- Sponsor's protocol ID
- IRB-DMC/2025/258
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial
- ClinicalTrials.gov ID
- NCT07578402
- Acronym / sponsor ID
- IRB-DMC/2025/258
- Keywords
- Dyspepsia, Post parendial distress syndrome (PPDS), Epigastric pain syndrome (EPS), Functional dyspepsia (FD), Disorder of gut brain interaction (DGBI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rakibul MostafaUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 May 2026 (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.
The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.
Participants will:
Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Drug: Digestive enzyme 325mgDrug: Digestive enzyme 325mg + first line treatment This group will get digestive enzyme 325 mg 3 times daily along with first line treatment (PPI 20 mg twice daily and Prokinetics such domperidone 10mg three time daily) for 1 month |
| Group-B | Active comparator | Drug: PPI 20 mg + Domperidone 10 mgDrug: First line treatment only This group will get first line treatment only ( PPI 20 mg twice daily and prokinetics such as domperidone 10 mg 3 times daily) for 1 month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or more
- Patients with FD diagnosed according to ROME IV criteria
Key exclusion criteria (6 listed)
- Structural lesion in endoscopy and positive H. pylori status
- History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders
- Psychiatric disorders
- Previous history gastrointestinal surgery
- Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme
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 |
|---|---|---|
| Digestive enzyme 325mgDigestive enzyme will be given to group A patient | Drug | Group-A |
| PPI 20 mg + Domperidone 10 mgGroup B patient will get first line treatment only for 1 month | Drug | Group-B |
Primary outcome
Change in dyspeptic symptom
Time frame: At baseline and then at week 2 and 4 after randomization
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
3 secondary outcomes
See the effect of digestive enzymes compared to first line treatment only
Time frame: At baseline and then at week 2 and 4 after randomization
Adverse events
Time frame: Through study completion, an average of 1 year
Persistence of symptom improvement or recurrence of dyspeptic symptoms
Time frame: At week 8 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Digestive enzyme 325mg and PPI 20 mg + Domperidone 10 mg in people with Dyspepsia and Functioanl Dyspepsia, run by Rakibul Mostafa at 1 site in Bangladesh.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 May 2026. 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 Bangladesh. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakibul Mostafa (+8801837031585, rakibmasuk96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspeptic symptom (time frame: At baseline and then at week 2 and 4 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.