Efficacy of Two Enzyme Cocktails in Healthy Adults (ElZyme)

The Archer-Daniels-Midland Company

Status: Not yet enrolling

Conditions: Digestive; Gastrointestinal Health

Treatments: Dietary Supplement: Placebo B; Dietary Supplement: Enzyme Cocktail B; Dietary Supplement: Enzyme Cocktail A; Dietary Supplement: Placebo A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06710392

CTB2022TN225D

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
• Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study
• Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months
• Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis
• Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.)
• Doctor diagnosed immunodeficiency
• Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
• Pregnancy, 6 months postpartum period, or current breastfeeding
• Women of childbearing age planning pregnancy during the course of the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

Digestive Enzyme Cocktail A

Experimental group

Description:

Arm receiving investigational product A

Treatment:

Dietary Supplement: Enzyme Cocktail A

Digestive Enzyme Cocktail B

Experimental group

Description:

Arm receiving investigational product B

Treatment:

Dietary Supplement: Enzyme Cocktail B

Placebo A

Placebo Comparator group

Description:

Arm receiving placebo A

Treatment:

Dietary Supplement: Placebo A

Placebo B

Placebo Comparator group

Description:

Arm receiving Placebo B

Treatment:

Dietary Supplement: Placebo B