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Not Yet RecruitingNCT06710392

Efficacy of Two Enzyme Cocktails in Healthy Adults

Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
The Archer-Daniels-Midland Company · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEnzyme Cocktail AEnzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTEnzyme Cocktail BEnzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTPlacebo APlacebo A matching investigational product A given 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTPlacebo BPlacebo B matching investigational product B given 3 times a day for 4 weeks.

Timeline

Start date
2024-12-15
Primary completion
2025-11-30
Completion
2025-11-30
First posted
2024-11-29
Last updated
2024-11-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06710392. Inclusion in this directory is not an endorsement.