Enzyme Cocktails for Gut Health

(ElZyme Trial)

Overseen By Dr. McFarlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Archer-Daniels-Midland Company

Must not be taking: Antibiotics, Prebiotics, Probiotics, Enzymes

Disqualifiers: Gastrointestinal illness, Chronic disease, Immunodeficiency, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using immunosuppressive agents or have taken antibiotics, prebiotics, probiotics, or digestive enzyme supplements in the past 3 months.

What data supports the effectiveness of the treatment Enzyme Cocktail A and Enzyme Cocktail B for gut health?

Research shows that enzyme therapies, including those with proteolytic enzymes like trypsin, chymotrypsin, and papain, have promising effects in reducing inflammation and improving quality of life in various conditions, such as cancer and pancreatitis. These enzymes have been shown to help with digestion and reduce side effects from other treatments, suggesting potential benefits for gut health. ^{1 2 3 4 5}

Is the enzyme cocktail treatment generally safe for humans?

The research does not provide specific safety data for enzyme cocktails in humans, but studies on related probiotics and synbiotics, like Bifidobacterium and lactobacilli, suggest they are generally safe and can improve gut health without adverse effects. ^{6 7 8 9 10}

How does the treatment Enzyme Cocktail A and B differ from other treatments for gut health?

Enzyme Cocktail A and B may offer a unique approach to gut health by potentially enhancing the synergy between ingested enzymes and those naturally present in the digestive tract, which could improve nutrient absorption and overall gut function. This treatment might also involve the translocation of enzymes across the gut barrier, providing additional health benefits not typically seen with standard gut health treatments. ^{1 9 11 12 13}

What is the purpose of this trial?

The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.

Eligibility Criteria

This trial is for healthy adults experiencing mild to moderate stomach discomfort. Participants must be willing to take enzyme cocktails or placebos and complete weekly questionnaires about their gut health. They also need to provide stool samples at the beginning and end of each treatment phase.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the enzyme cocktail or placebo for 4 weeks, with weekly questionnaires and stool sample collection at the start and end of each treatment period

8 weeks

Weekly visits for questionnaires and stool sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enzyme Cocktail A
• Enzyme Cocktail B

Trial Overview The study tests the safety and effectiveness of two different enzyme cocktails compared with placebos over a period of 4 weeks. The impact on gastrointestinal health is measured through weekly questionnaires and analysis of stool samples before and after treatment.

Participant Groups

Group I: Digestive Enzyme Cocktail B Experimental Treatment 1 Intervention

Arm receiving investigational product B

Group II: Digestive Enzyme Cocktail A Experimental Treatment 1 Intervention

Arm receiving investigational product A

Group III: Placebo A Placebo Group 1 Intervention

Arm receiving placebo A

Group IV: Placebo B Placebo Group 1 Intervention

Arm receiving Placebo B

Who Is Running the Clinical Trial?

The Archer-Daniels-Midland Company

Lead Sponsor

Trials

17

Recruited

1,400+

University of North Texas, Denton, TX

Collaborator

Trials

13

Recruited

7,100+

References

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

Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? [2020]

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

Oral pancreatic enzyme therapy in the control of diabetes mellitus in tropical calculous pancreatitis. [2023]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

Pharmacological effects of oral enzyme combinations. [2006]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Systemic enzyme therapy in oncology: effect and mode of action. [2018]

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

Management of chronic pancreatitis. Focus on enzyme replacement therapy. [2018]

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

Dosing a synbiotic of human milk oligosaccharides and B. infantis leads to reversible engraftment in healthy adult microbiomes without antibiotics. [2022]

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

Inhibitory effects of Bifidobacterium spp. isolated from a healthy Korean on harmful enzymes of human intestinal microflora. [2019]

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

A review on enzyme-producing lactobacilli associated with the human digestive process: From metabolism to application. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Meta-analysis identifies the effect of dietary multi-enzyme supplementation on gut health of pigs. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic Cocktail Alleviates Intestinal Inflammation Through Improving Gut Microbiota and Metabolites in Colitis Mice. [2022]

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

On the synergistic effects of enzymes in food with enzymes in the human body. A literature survey and analytical report. [2019]

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

Translocation of health-promoting enzymes across the gut barrier. [2023]

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

Functional and comparative metagenomic analysis of bile salt hydrolase activity in the human gut microbiome. [2021]