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Enzyme Cocktail
Enzyme Cocktails for Gut Health (ElZyme Trial)
Denton, TX
N/A
Waitlist Available
Research Sponsored by The Archer-Daniels-Midland Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 28, day 42, and day 70
Summary
This trial aims to see if two enzyme cocktails can help with gut health in healthy adults with mild to moderate gastrointestinal discomfort. Participants will take one of the cocktails for 4 weeks and then switch to a
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves healthy adults, side effects are expected to be minimal but may include temporary changes in digestion or bowel habits due to the introduction of new enzymes into the diet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 28, day 42, and day 70
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 28, day 42, and day 70
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
Secondary study objectives
Body Mass Index (BMI)
Change from baseline in Stool Consistency at end of intervention
Change from baseline in the Stool Frequency at end of intervention
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Digestive Enzyme Cocktail BExperimental Treatment1 Intervention
Arm receiving investigational product B
Group II: Digestive Enzyme Cocktail AExperimental Treatment1 Intervention
Arm receiving investigational product A
Group III: Placebo APlacebo Group1 Intervention
Arm receiving placebo A
Group IV: Placebo BPlacebo Group1 Intervention
Arm receiving Placebo B
Find a Location
Closest Location:The University of North Texas· Denton, TX· 317 miles
Who is running the clinical trial?
The Archer-Daniels-Midland CompanyLead Sponsor
16 Previous Clinical Trials
1,782 Total Patients Enrolled
University of North Texas, Denton, TXOTHER
12 Previous Clinical Trials
6,961 Total Patients Enrolled