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

Rakibul Mostafa

Status and phase: Not yet enrolling; Phase 4

Conditions: Functioanl Dyspepsia; Dyspepsia; Epigastric Fullness; Epigastric Pain Syndrome

Treatments: Drug: Digestive enzyme 325mg; Drug: PPI 20 mg + Domperidone 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07578402

IRB-DMC/2025/258

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Group-A

Experimental group

Description:

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

Treatment:

Drug: Digestive enzyme 325mg

Group-B

Active Comparator group

Description:

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

Treatment:

Drug: PPI 20 mg + Domperidone 10 mg