Digestive Enzymes for Indigestion

Overseen By Stephanie Recker

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Pancap Pharma Inc.

Disqualifiers: Diabetes, Hypertension, Thyroid disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a digestive enzyme blend can break down fats, proteins, and carbohydrates, especially after high-fat, high-protein meals. It aims to determine if these enzymes can reduce symptoms like bloating and gas. The study compares the enzyme blend to a placebo (a pill with no active ingredients) to assess its effectiveness. Individuals who frequently experience indigestion after high-fat, high-protein meals and are in good general health might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications to join the trial?

The trial requires participants to maintain consistent medication and supplement intake throughout the study, except for the high-fat, high-protein meals. However, you must agree to follow restrictions on other treatments, so it's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research on digestive enzyme blends, like the one being tested, shows promising safety results. Studies have found no harmful effects or allergic reactions in people using similar enzyme blends. Other research has shown these supplements to be effective and safe for managing symptoms like indigestion. These digestive enzymes are also commonly used in food and animal feeds without safety issues. Since this trial is in Phase 2, earlier tests have demonstrated the treatment's safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Digestive Enzyme Blend for indigestion because it uses porcine pancreatic enzymes, which offer a different approach compared to standard treatments like antacids or proton pump inhibitors. Unlike these common treatments that neutralize stomach acid or reduce its production, the enzyme blend aids digestion by providing natural enzymes that help break down food more effectively. This method could lead to quicker relief from indigestion symptoms by directly supporting the digestive process rather than just addressing acid levels.

What evidence suggests that this treatment might be an effective treatment for indigestion?

Research has shown that digestive enzyme supplements can help reduce indigestion symptoms. In this trial, participants will receive either a Digestive Enzyme Blend or a placebo. Studies have found that these enzymes can ease discomfort and improve sleep for people with functional dyspepsia, a type of indigestion. For individuals who don't naturally produce enough digestive enzymes, these supplements can help break down fats, proteins, and carbohydrates. This can lead to less bloating and discomfort after eating, especially with meals high in fat or protein. Overall, digestive enzymes have shown promise in improving digestion without causing negative side effects. ^{1 3 4 6 7}

Who Is on the Research Team?

Toni Matoski

Principal Investigator

Pancap Pharma Inc.

John Mikhail

Principal Investigator

Pancap Pharma Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-60 with a BMI of 18.5 to 29.9, non-smokers, and no recent history of alcohol or substance abuse. Participants must not be pregnant, planning pregnancy, or have significant health issues like heart disease, diabetes, high blood pressure, thyroid disease, gastrointestinal disorders or cancer within the last five years.

Inclusion Criteria

In good general health as determined by the investigator

BMI between 18.5 to 29.9 kg/m2

Weigh at least 60 kilograms at screening and baseline

Exclusion Criteria

Lactating, pregnant, planning pregnancy, or positive pregnancy test at Visit 2

Known sensitivity, intolerability, or allergy to study products or their excipients

Following or planning to follow a restrictive diet during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of the enzyme supplement and are monitored for immediate effects on digestion and post-meal symptoms

1 day

1 visit (in-person)

Extended Treatment

Participants continue enzyme supplementation for 7 days to assess longer-term benefits on digestion and quality of life

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digestive Enzyme Blend

Trial Overview

The study tests if a porcine-derived enzyme blend can improve digestion and reduce discomfort after consuming high-fat and high-protein meals compared to a placebo. It aims to determine the effectiveness in nutrient absorption and alleviating symptoms such as bloating and gas.

How Is the Trial Designed?

Group I: Digestive Enzyme Blend Active Control 1 Intervention

Active ingredients: Porcine Pancreatic Enzyme

Group II: Placebo Placebo Group 1 Intervention

Active ingredients: None

Who Is Running the Clinical Trial?

Pancap Pharma Inc.

Lead Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Published Research Related to This Trial

The FDA's Adverse Reaction Monitoring System (ARMS) is crucial for tracking consumer reports of adverse reactions to food additives, helping to identify potential public health risks associated with these substances.

Sulfiting agents and aspartame have been the most frequently reported food additives linked to adverse reactions, highlighting the need for ongoing monitoring and investigation of these additives' safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring adverse reactions to food additives in the U.S. Food and Drug Administration. Tollefson, L.[2019]

In a study of 30 patients with functional dyspepsia, ranitidine significantly improved heartburn severity compared to placebo, particularly in those with reflux-like dyspepsia, indicating its efficacy for this subgroup.

The study highlights that not all patients with functional dyspepsia respond the same way to ranitidine, suggesting that treatment may need to be tailored based on specific symptom profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ranitidine therapeutically effective in functional dyspepsia with reflux-like symptoms]. Jebbink, HJ., Smout, AJ., van Berge Henegouwen, GP.[2013]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0753332223016566

Efficacy of digestive enzyme supplementation in functional ...

Treatment with digestive enzymes was found to be effective in the reduction of functional dyspepsia symptoms and in the improvement of sleep quality, and is ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37976892/

Efficacy of digestive enzyme supplementation in functional ...

Treatment with digestive enzymes was found to be effective in the reduction of functional dyspepsia symptoms and in the improvement of sleep quality, and is ...

3.

withpower.com

withpower.com/trial/digestive-enzymes-for-indigestion-25130

Digestive Enzymes for Indigestion · Info for Participants

Research shows that taking a multi-enzyme blend can improve symptoms of functional dyspepsia (a type of indigestion) by reducing pain and improving sleep ...

4.

dovepress.com

dovepress.com/a-multi-digestive-enzyme-and-herbal-dietary-supplement-reduces-bloatin-peer-reviewed-fulltext-article-NDS

Multi-digestive enzyme & dietary supplement reduces ...

Digestive enzymes and herbal dietary supplements effectively reduced post-meal abdominal distension in healthy subjects, without adverse effects.

5.

hopkinsmedicine.org

hopkinsmedicine.org/health/wellness-and-prevention/digestive-enzymes-and-digestive-enzyme-supplements

Digestive Enzymes and Digestive Enzyme Supplements

Digestive enzyme supplements help people with enzyme insufficiencies digest their food and absorb nutrients. Most healthy people don't need additional ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6249666/

A Randomized, Double-Blind, Placebo-Controlled Study

MEC supplementation represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4923703/

Digestive Enzyme Supplementation in Gastrointestinal ...

Until April 2010, pancreatic replacement therapy did not require safety and efficacy data to be submitted to FDA. Since April 2010, FDA required clinical trials ...