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

Trial Summary

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.

What data supports the effectiveness of the treatment Digestive Enzyme Blend for indigestion?

Research shows that taking a multi-enzyme blend can improve symptoms of functional dyspepsia (a type of indigestion) by reducing pain and improving sleep quality, without causing side effects. ^{1 2 3 4 5}

Is the Digestive Enzyme Blend safe for human use?

Research on similar enzyme blends, like those used in food and animal feed, shows no safety concerns for humans. Studies found no toxic effects or allergic reactions, suggesting these enzymes are generally safe for consumption. ^{6 7 8 9 10}

How does the Digestive Enzyme Blend treatment for indigestion differ from other treatments?

The Digestive Enzyme Blend is unique because it uses a multi-enzyme preparation obtained from fungal fermentation, which has been shown to improve quality of life and reduce symptoms of indigestion without side effects. This blend is different from other treatments as it specifically targets enzyme deficiencies that may cause indigestion, and it is well-tolerated by patients. ^{2 3 11 12 13}

What is the purpose of this trial?

This study aims to show how digestive enzyme supplements help the body break down fats, proteins, and carbohydrates, especially after eating a high-fat, high-protein meal. Digestive enzymes are essential for nutrient absorption, but some people-such as those with certain medical conditions or high-protein diets-may not produce enough on their own. Poor digestion can lead to bloating, discomfort, and gut imbalances. This clinical trial tests a delayed-release, porcine-derived enzyme blend to see if it improves digestion and reduces symptoms like bloating and gas after eating a high-fat and high protein meal.

Research Team

Toni Matoski

Principal Investigator

Pancap Pharma Inc.

John Mikhail

Principal Investigator

Pancap Pharma Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Ranitidine therapeutically effective in functional dyspepsia with reflux-like symptoms]. [2013]

2. China pubmed.ncbi.nlm.nih.gov

[Efficacy of compound digestive enzyme tablet for dyspeptic symptoms: a randomized double-blind parallel controlled multicenter clinical trial in China]. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect on bioavailability of admixing the contents of lansoprazole capsules with selected soft foods. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Proton pump inhibitors: effective first-line treatment for management of dyspepsia. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Amylofeed® (endo-1,3(4)-β-glucanase and endo-1,4-β-xylanase and α-amylase) as a feed additive for piglets and minor porcine species. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Safety evaluation of the food enzyme β-glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM-ST). [2020]

10. England pubmed.ncbi.nlm.nih.gov

Food Enzyme Database (FEDA): a web application gathering information about food enzyme preparations available on the European market. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[High-dose enzyme-substitution therapy in digestive disorders]. [2018]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Involutory maldigestion]. [2018]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Multiple-enzyme supplementation on digestive traits, carcass characteristics, blood lipid parameters and growth performance of broilers fed a wheat-based diet. [2020]