Efficacy of Two Enzyme Cocktails in Healthy Adults (ElZyme)

May 7, 2026 updated by: The Archer-Daniels-Midland Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Denton, Texas, United States, 76201
        • The University of North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digestive Enzyme Cocktail A
Arm receiving investigational product A
Dietary supplement: Enzyme Cocktail A
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
Experimental: Digestive Enzyme Cocktail B
Arm receiving investigational product B
Dietary supplement: Enzyme Cocktail B
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
Placebo Comparator: Placebo A
Arm receiving placebo A
Dietary supplement: Placebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo Comparator: Placebo B
Arm receiving Placebo B
Dietary supplement: Placebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
Time Frame: From baseline to the end of intervention 4 weeks later.
Change in GSRS-IBS total score from baseline to end of intervention. Each question is rated on a 7 point Likert scale with higher scores representing more troublesome symptoms. Questionnaire collected weekly from baseline through study completion at the end of week 12.
From baseline to the end of intervention 4 weeks later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Stool Consistency at end of intervention
Time Frame: Through study completion, an expected average of 70 days
Difference in weekly self reported stool consistency, as measured by the Bristol Stool Form Scale (BSFS) on a daily basis. BSFS max score 7 - lower scores indicate constipation, higher scores indicate diarrhea.
Through study completion, an expected average of 70 days
Change from baseline in the Stool Frequency at end of intervention
Time Frame: Through study completion, an expected average of 70 days
Change in weekly average stool frequency throughout the period between baseline and end of intervention.
Through study completion, an expected average of 70 days
Change in Microbiome (faecal samples)
Time Frame: Day 0 and Day 28; Day 42 and Day 70
Change in stool microbiome between baseline and end of intervention for each of cross over runs (Change between day 0 and day 28, change between day 42 and 70)
Day 0 and Day 28; Day 42 and Day 70
Body Mass Index (BMI)
Time Frame: Day 0, Day 28, Day 42, and Day 70
Participants whole-body weight [kg] and height [m] will be measured and BMI will be calculated as kg/m^2
Day 0, Day 28, Day 42, and Day 70
Total Fat Mass
Time Frame: Day 0, Day 28, Day 42, and Day 70
Participants total fat mass (kg) will be tested using a BIA scale.
Day 0, Day 28, Day 42, and Day 70
Food Intake
Time Frame: Day 0
Food intake is measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data to measure habitual food intake at baseline.
Day 0
Positive and Negative Affect Schedule (PANAS-SF)
Time Frame: Day 0, Day 28, Day 42, and Day 70
The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Day 0, Day 28, Day 42, and Day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Archer-Daniels-Midland Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of North Texas, Denton, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTB2022TN225D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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