Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07578402

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dyspepsia Epigastric Fullness Epigastric Pain Syndrome Functioanl Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digestive enzyme 325mg

Drug

Digestive enzyme will be given to group A patient

PPI 20 mg + Domperidone 10 mg

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Adverse events

    Time frame: Through study completion, an average of 1 year

    Patient reported adverse events will be documented

  3. Persistence of symptom improvement or recurrence of dyspeptic symptoms

    Time frame: At week 8 after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rakibul Mostafa

CONTACT

[email protected]

+8801837031585

Sponsors and collaborators

Lead sponsor

Rakibul Mostafa

Other

Registry information

Official study title

Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.