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

NCT07578402 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRB-DMC/2025/258
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dyspepsia; Functioanl Dyspepsia; Epigastric Pain Syndrome; Epigastric Fullness

Keywords

Dyspepsia; Post parendial distress syndrome (PPDS); Epigastric pain syndrome (EPS); Functional dyspepsia (FD); Disorder of gut brain interaction (DGBI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• See the effect of digestive enzymes compared to first line treatment only

  At baseline and then at week 2 and 4 after randomization

• Adverse events

  Through study completion, an average of 1 year

• Persistence of symptom improvement or recurrence of dyspeptic symptoms

  At week 8 after randomization

Study Arms (2)

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

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

Drug: PPI 20 mg + Domperidone 10 mg

Interventions

PPI 20 mg + Domperidone 10 mg DRUG

Group B patient will get first line treatment only for 1 month

Group-B

Digestive enzyme 325mg DRUG

Digestive enzyme will be given to group A patient

Group-A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rakibul Mostafa: lead

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Domperidone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Rakibul Mostafa

CONTACT

+8801837031585; rakibmasuk96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)