Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Dyspepsia; Epigastric Fullness; Epigastric Pain Syndrome; Functioanl Dyspepsia
• Intervention / Treatment: Drug: Digestive enzyme 325mg; Drug: PPI 20 mg + Domperidone 10 mg

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rakibul Mostafa; Phone Number: +8801837031585; Email: rakibmasuk96@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Dhaka Medical College
    • Contact: Rakibul Mostafa; Phone Number: +8801837031585; Email: rakibmasuk96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 years or more
• Patients with FD diagnosed according to ROME IV criteria

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-A; 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	Drug: Digestive enzyme 325mg; Digestive enzyme will be given to group A patient
Active Comparator: Group-B; 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	Drug: PPI 20 mg + Domperidone 10 mg; Group B patient will get first line treatment only for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and then at week 2 and 4 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Patient reported adverse events will be documented	Through study completion, an average of 1 year
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.	At baseline and then at week 2 and 4 after randomization
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.	At week 8 after randomization

Collaborators and Investigators

• Sponsor: Rakibul Mostafa

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dyspepsia; Functional dyspepsia (FD); Post parendial distress syndrome (PPDS); Epigastric pain syndrome (EPS); Disorder of gut brain interaction (DGBI)
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspepsia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Domperidone
• Other Study ID Numbers: IRB-DMC/2025/258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No