DigestiveElZymeNCT06710392
Efficacy of Two Enzyme Cocktails in Healthy Adults
A study testing Enzyme Cocktail A and Enzyme Cocktail B in people with Digestive and Gastrointestinal Health, run by The Archer-Daniels-Midland Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive, Gastrointestinal Health
- What is being tested?
- Enzyme Cocktail A and Enzyme Cocktail B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Digestive, Gastrointestinal Health
- Being tested
- Enzyme Cocktail A, Enzyme Cocktail B, Placebo A, Placebo B
- Keywords
- enzyme, enzyme cocktail, healthy adults, nutraceutical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme Cocktail ADietary supplement
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
Enzyme Cocktail BDietary supplement
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
Placebo ADietary supplement
Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo BDietary supplement
Placebo B matching investigational product B given 3 times a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Digestive Enzyme Cocktail A | Experimental | Arm receiving investigational product A Receives: Dietary Supplement: Enzyme Cocktail A |
| Digestive Enzyme Cocktail B | Experimental | Arm receiving investigational product B Receives: Dietary Supplement: Enzyme Cocktail B |
| Placebo A | Placebo comparator | Arm receiving placebo A Receives: Dietary Supplement: Placebo A |
| Placebo B | Placebo comparator | Arm receiving Placebo B Receives: Dietary Supplement: Placebo B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
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.
Measured: From baseline to the end of intervention 4 weeks later.
Secondary outcomes (7)
Change from baseline in Stool Consistency at end of intervention
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.
Measured: Through study completion, an expected average of 70 days
Change from baseline in the Stool Frequency at end of intervention
Change in weekly average stool frequency throughout the period between baseline and end of intervention.
Measured: Through study completion, an expected average of 70 days
Change in Microbiome (faecal samples)
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)
Measured: Day 0 and Day 28; Day 42 and Day 70
Body Mass Index (BMI)
Participants whole-body weight [kg] and height [m] will be measured and BMI will be calculated as kg/m^2
Measured: Day 0, Day 28, Day 42, and Day 70
Total Fat Mass
Participants total fat mass (kg) will be tested using a BIA scale.
Measured: Day 0, Day 28, Day 42, and Day 70
Food Intake
Food intake is measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data to measure habitual food intake at baseline.
Measured: Day 0
Positive and Negative Affect Schedule (PANAS-SF)
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).
Measured: Day 0, Day 28, Day 42, and Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start29 May 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Why it stopped: The study was terminated due to insufficient enrollment and recruitment struggles
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DigestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Texas, Denton, TX
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710392
- Sponsor's protocol ID
- CTB2022TN225D
- Acronym
- ElZyme
- Status last verified
- May 2026
- First submitted
- 26 Nov 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints
- ClinicalTrials.gov ID
- NCT06710392
- Acronym / sponsor ID
- ElZyme / CTB2022TN225D
- Conditions
- Digestive, Gastrointestinal Health
- Keywords
- enzyme, enzyme cocktail, healthy adults, nutraceutical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to insufficient enrollment and recruitment struggles
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- University of North Texas, Denton, TX
- Study start
- 29 May 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Digestive Enzyme Cocktail A | Experimental | Dietary Supplement: Enzyme Cocktail AArm receiving investigational product A |
| Digestive Enzyme Cocktail B | Experimental | Dietary Supplement: Enzyme Cocktail BArm receiving investigational product B |
| Placebo A | Placebo comparator | Dietary Supplement: Placebo AArm receiving placebo A |
| Placebo B | Placebo comparator | Dietary Supplement: Placebo BArm receiving Placebo B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzyme 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 supplement | Digestive Enzyme Cocktail A |
| Enzyme 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 supplement | Digestive Enzyme Cocktail B |
| Placebo APlacebo A matching investigational product A given 3 times a day for 4 weeks. | Dietary supplement | Placebo A |
| Placebo BPlacebo B matching investigational product B given 3 times a day for 4 weeks. | Dietary supplement | Placebo B |
Primary outcome
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.
7 secondary outcomes
Change from baseline in Stool Consistency at end of intervention
Time frame: 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 Microbiome (faecal samples)
Time frame: 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
Total Fat Mass
Time frame: Day 0, Day 28, Day 42, and Day 70
Food Intake
Time frame: Day 0
Positive and Negative Affect Schedule (PANAS-SF)
Time frame: Day 0, Day 28, Day 42, and Day 70
Results and safety
The study was stopped early (reason given: The study was terminated due to insufficient enrollment and recruitment struggles). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enzyme Cocktail A and Enzyme Cocktail B in people with Digestive and Gastrointestinal Health, run by The Archer-Daniels-Midland Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to insufficient enrollment and recruitment struggles). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) (time frame: From baseline to the end of intervention 4 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.