Upper Gastrointestinal DiscomfortNCT07913711
Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort
A study testing Mānuka Honey Active Product 1 and Mānuka Honey Active Product 2 in people with Upper Gastrointestinal Discomfort, run by Radicle Science at 1 site in United States.
Trial summary
Impact of Lepteridine™ Mānuka honey in adults with gastrointestinal discomfort: a randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Discomfort
- What is being tested?
- Mānuka Honey Active Product 1 and Mānuka Honey Active Product 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 775 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 28 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
- Resides in the United States
- Reports experiencing pain or burning in their upper abdomen at least once a week
- Reports experiencing mild to severe discomfort in their upper abdomen
- Reports no physical cause for their GI symptoms
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Who cannot join
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk
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- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. This may include:
- NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. This may include:
- Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, Proton Pump Inhibitors, or thyroid products
- Reports vomiting once per week or more due to GI discomfort
- Reports taking antibiotics within the month before starting the study
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
- Medical history of upper GI surgery or other diagnosed significant disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease)
- Lack of reliable daily access to the internet Biomarker collection note: participants residing in New York, New Jersey, or Rhode Island may enroll in the main study but are not eligible for the optional biospecimen collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Radicle Science, Inc
Del Mar, California, 92014
Study Manager, 760-281-3898, studymgmt@radiclescience.com
Megan Moseley, megan@radiclescience.com
About this study
Official title: Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort: A Randomized, Double-Blind, Placebo-Controlled Trial
Impact of Lepteridine™ Mānuka honey in adults with gastrointestinal discomfort: a randomized, double-blind, placebo-controlled trial.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) experience pain or burning in their upper abdomen at least once a week, (2) experience mild to severe discomfort in their upper abdomen, (3) experiencing vomiting less than once per week due to GI discomfort, (4) reports no physical cause for GI symptoms, and (5) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- Upper Gastrointestinal Discomfort
- Being tested
- Mānuka Honey Active Product 1, Mānuka Honey Active Product 2, Placebo Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mānuka Honey Active Product 1Other
Participants will use their Mānuka Honey Active Product 1 as directed for a period of 6 weeks.
Mānuka Honey Active Product 2Other
Participants will use their Mānuka Honey Active Product 2 as directed for a period of 6 weeks.
Placebo ControlOther
Participants will use their Placebo Control as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Product 1 | Experimental | Mānuka Honey Active Product 1 Receives: Other: Mānuka Honey Active Product 1 |
| Active Product 2 | Experimental | Mānuka Honey Active Product 2 Receives: Other: Mānuka Honey Active Product 2 |
| Placebo Control | Placebo comparator | Placebo Control Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper GI discomfort symptoms
Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort symptom scores, as assessed by the Nepean Dyspepsia Index (NDI) symptom checklist (scale 0-195; higher scores indicate more severe symptoms).
Measured: Baseline to Week 6
Change in upper GI discomfort related quality of life
Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort-related quality of life, as assessed by the Nepean Dyspepsia Index (NDI) quality of life subscale (scale 0-100; higher scores indicate better quality of life).
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start28 Oct 2026 (estimated)
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal DiscomfortStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Participants will be stratified based on their assigned sex at birth, age group (21-44, 45-64, 65+), and biospecimen collection participation (yes/no) during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 775 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913711
- Sponsor's protocol ID
- RADX_P_2607_DCM
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07913711
- Acronym / sponsor ID
- RADX_P_2607_DCM
- Conditions
- Upper Gastrointestinal Discomfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 775 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Impact of Lepteridine™ Mānuka honey in adults with gastrointestinal discomfort: a randomized, double-blind, placebo-controlled trial.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) experience pain or burning in their upper abdomen at least once a week, (2) experience mild to severe discomfort in their upper abdomen, (3) experiencing vomiting less than once per week due to GI discomfort, (4) reports no physical cause for GI symptoms, and (5) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be stratified based on their assigned sex at birth, age group (21-44, 45-64, 65+), and biospecimen collection participation (yes/no) during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
| Arm | Type | Receives |
|---|---|---|
| Active Product 1 | Experimental | Other: Mānuka Honey Active Product 1Mānuka Honey Active Product 1 |
| Active Product 2 | Experimental | Other: Mānuka Honey Active Product 2Mānuka Honey Active Product 2 |
| Placebo Control | Placebo comparator | Other: Placebo ControlPlacebo Control |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Resides in the United States
- Reports experiencing pain or burning in their upper abdomen at least once a week
- Reports experiencing mild to severe discomfort in their upper abdomen
- Reports no physical cause for their GI symptoms
Key exclusion criteria (15 listed)
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
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 |
|---|---|---|
| Mānuka Honey Active Product 1Participants will use their Mānuka Honey Active Product 1 as directed for a period of 6 weeks. | Other | Active Product 1 |
| Mānuka Honey Active Product 2Participants will use their Mānuka Honey Active Product 2 as directed for a period of 6 weeks. | Other | Active Product 2 |
| Placebo ControlParticipants will use their Placebo Control as directed for a period of 6 weeks. | Other | Placebo Control |
Primary outcome
Change in upper GI discomfort symptoms
Time frame: Baseline to Week 6
Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort symptom scores, as assessed by the Nepean Dyspepsia Index (NDI) symptom checklist (scale 0-195; higher scores indicate more severe symptoms).
Change in upper GI discomfort related quality of life
Time frame: Baseline to Week 6
Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort-related quality of life, as assessed by the Nepean Dyspepsia Index (NDI) quality of life subscale (scale 0-100; higher scores indicate better quality of life).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mānuka Honey Active Product 1 and Mānuka Honey Active Product 2 in people with Upper Gastrointestinal Discomfort, run by Radicle Science 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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 6 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (858-779-0086, studymgmt@radiclescience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper GI discomfort symptoms (time frame: Baseline to Week 6). The study lists 2 primary outcomes in all. 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 6 Nov 2026.